Job Summary

Responsibilities

•     Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation and complaint has on the product, process, and patient health and safety.        

• As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.

• Prepares and analyzes manufacturing and laboratory analytical historical data and uses methodical root-cause analysis tools to determine root causes and effectively communicates the root cause to senior management.     

• The incumbent will need to properly assess the manufacturing or analytical environment, independently conceive, and advise senior management on appropriate corrective/preventative actions designed to mitigate Quality deficiencies identified in the investigative process using industry accepted analytical tools.     

• The individual in the position provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.    

• Updates and maintains all related enterprise quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.     

• Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.     

• Demonstrates strong technical skills; provides technical assistance to area supervisors, managers, and technical writers to solve complex problems.

• Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.   

• Accountable for commitments agreed upon with department management. Required to comply with closure targets and provide adequate justification if commitments are not met.   

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.  

• Any other task as directed or requested by management or site leadership.

REQUIREMENTS

•     BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience

•     3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.

•     Good deductive and inductive critical thinking skills required.

•     Advanced technical writing skills required.

•     Candidate must possess strong interpersonal, written, and verbal communication skills.  Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.  Good knowledge of MS Office programs, including Word and Excel.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

We offer state of the art equipment, room for growth and great benefits such as:

401(k)

Dental insurance and vision insurance

Employee assistance program

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Professional development assistance

Referral program

Tuition reimbursement

Responsibilities

• Supervises manufacturing group leaders and hourly staff in proper operating techniques and procedures.
• Develops information and compiles reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested.
• Assists in establishing production schedules.
• Confers with other department management to coordinate the scheduling of operations to achieve required deadlines.
• Develops department employees through orientation, training, establishment of objectives, communication of rules and policies while building employee morale and motivation.
• Maintains compliance with company policies, cGMP’s, safety standards, and good housekeeping practices.
• Monitors and controls production schedules and activities to ensure the meeting of departmental performance objectives and budgets.
• Supervises, coordinates and controls the production and operating activities to ensure optimum utilization of personnel, materials, and equipment.
• Conducts continuous review and follow-up on projects to ensure completion of assigned work.
• Evaluates the performance and production of staff; maintains records on performance.
• Advises department management on matters relating to daily operations and makes recommendations for improvements when feasible.
• Recommends and implements value and process improvement programs.
• Ensures adequate resources are available to manufacture product (equipment, supplies, and labor).
• Performs/ensures investigations and document corrections/modifications are done effectively and in a timely manner.

Requirements

• Bachelor of Science degree plus two to three years supervisory experience in a pharmaceutical or food plant required.
• Chemistry knowledge required
• Proven leadership skills.
• Proven communication and employee relations skills necessary.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

Our Production Technicians are vital to the success of our business as we produce lifesaving medicines, one vial at a time.

As a Production Technician, we provide you with opportunities to expand your career within Fresenius Kabi in Compounding, Filling, Maintenance, Microbiology, Validation, Engineering, Packaging, and other areas of expertise. Come build a lasting career with Fresenius-Kabi as we work as a team to fulfill our mission of Caring For Life!

Job Description

What is it like working as a Production Technician for Fresenius-Kabi?

• Learn how to fully operate, set-up, fine-tune and troubleshoot various Production Machines and Equipment through advanced HMI applications (Formulation Tanks, Filling Machine, Capping Machine, Lyophilizer [Freeze-Dryer], and Component Sterilizers – just to name a few!)

• Understand the process flow and step by step requirements for manufacturing

• Understand and follow aseptic practices to ensure the safety of our products

• Clean and sanitize equipment and production rooms

• Order, transfer and return materials for each new Production Batch

• Train and comply with current SOP’s and GMP’s

• Maintain accurate records and data timely

• Follow safety requirements and promote a safe working environment

• Concise communication with co-workers and managers to promote a teamwork atmosphere

As you start your role, we offer mentorship, coaching, training and guidance to get you up to speed!

Requirements

• Applicants must meet the following criteria to be eligible to apply:

• Have a minimum of a High School Diploma, GED or equivalent education

• Able to work 12hr shifts on a 3-2-2-3 schedule

• Able to stand on concrete floors for an extended period of time

• Able to lift 35 pounds by bending and lifting

• Wear required safety personal protective equipment (eye protection, safety shoes, gown, gloves)

• Must be able to understand, speak, and write English in order to comply with necessary SOP’s, SPEC’s, Job-specific training materials, GMP’s, and other manuals

What experience will help you as you start your career with Fresenius-Kabi?

• At least 1 year of manufacturing experience, including operating, maintaining and cleaning automated equipment

• Experience in the Pharmaceutical or Food Industries is a plus, not required

• Experience using Aseptic Technique is a plus, not required

• Basic and/or advanced math skills

• Basic mechanical knowledge (hands-on troubleshooting and adjusting equipment)

We offer state of the art equipment, room for growth and great benefits such as:

401(k)

Medical, dental and vision insurance

Pet insurance

Employee assistance program

Flexible spending account

Health savings account

Life insurance

Paid time off

Parental leave

Referral program

Tuition reimbursement

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

Are you ready to join our growing team at Fresenius-Kabi? We’re looking for team players who can gain new skills to help run and maintain the latest production technology and equipment for one of the world’s largest injectable drug manufacturer!

We offer state of the art equipment, room for growth and great benefits such as:

401(k)

Medical, dental and vision insurance

Pet insurance

Employee assistance program

Flexible spending account

Health savings account

Life insurance

Paid time off

Parental leave

Referral program

Tuition reimbursement

Our Production Technicians are vital to the success of our business as we produce lifesaving medicines, one vial at a time.

As a Production Technician, we provide you with opportunities to expand your career within Fresenius Kabi in Compounding, Filling, Maintenance, Microbiology, Validation, Engineering, Packaging, and other areas of expertise. Come build a lasting career with Fresenius-Kabi as we work as a team to fulfill our mission of Caring For Life!

Job Description

What is it like working as a Production Technician for Fresenius-Kabi?

• Learn how to fully operate, set-up, fine-tune and troubleshoot various Production Machines and Equipment through advanced HMI applications (Formulation Tanks, Filling Machine, Capping Machine, Lyophilizer [Freeze-Dryer], and Component Sterilizers – just to name a few!)

• Understand the process flow and step by step requirements for manufacturing

• Understand and follow aseptic practices to ensure the safety of our products

• Clean and sanitize equipment and production rooms

• Order, transfer and return materials for each new Production Batch

• Train and comply with current SOP’s and GMP’s

• Maintain accurate records and data timely

• Follow safety requirements and promote a safe working environment

• Concise communication with co-workers and managers to promote a teamwork atmosphere

As you start your role, we offer mentorship, coaching, training and guidance to get you up to speed!

Requirements

• Applicants must meet the following criteria to be eligible to apply:

• Have a minimum of a High School Diploma, GED or equivalent education

• Able to work 12hr shifts on a 3-2-2-3 schedule

• Able to stand on concrete floors for an extended period of time

• Able to lift 35 pounds by bending and lifting

• Wear required safety personal protective equipment (eye protection, safety shoes, gown, gloves)

• Must be able to understand, speak, and write English in order to comply with necessary SOP’s, SPEC’s, Job-specific training materials, GMP’s, and other manuals

What experience will help you as you start your career with Fresenius-Kabi?

• At least 1 year of manufacturing experience, including operating, maintaining and cleaning automated equipment

• Experience in the Pharmaceutical or Food Industries is a plus, not required

• Experience using Aseptic Technique is a plus, not required

• Basic and/or advanced math skills

• Basic mechanical knowledge (hands-on troubleshooting and adjusting equipment)

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

·       Performs visual inspection of lot numbers, expiration dates, inserts, trays, partitions, over packs, packing and palletizing over packs

·       Will work on assembly lines with high speed computer-based equipment with HMI applications

·       Assures that the packaged product meets all [100%] of specifications

·       Responsible for complying with all SOP’s and cGMP’s.

·       Responsible for complying with training.

·       Maintains a clean and organized work environment and strives to meet daily goals

·       Makes minor adjustments and assists with changeover and set-up to equipment, as necessary

·       Performs and documents line clearances before and after the running of each batch.

·       Assures a safe working environment and wears appropriate safety equipment/apparel at all times as well as alerting the supervisor to unsafe conditions in the department

·       Performs other duties as assigned

·       Works overtime as needed

REQUIREMENTS

·       High school diploma or equivalency required

·       One – Three years of manufacturing/packaging experience

·       Basic problem solving, mechanical skills required

·       Good communication skills are necessary

·       Attention to detail is essential

·       Ability to lift up to 40 lbs to waist high regularly is required

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Sets-up, adjusts, and operates equipment such as secondary labeler/s, Domino Ink Jet printers, Shanklin, Tex-wrap and the STS heat wrapping machines, tap machines etc.

• Performs and documents critical steps of packaging operation such as line clearance, label verification, product count, final finished goods verification, etc.

• Performs and documents quality checks on inserts, labeled/packed product etc.

• Labels and packages product according to packaging batch record.  Assesses quality of each component packed and designates components for rework or reject if needed.

• Performs labeling accountability calculations on batch record.

• Loads vials on turntables, assembles print block, Stacks, wraps and moves pallets of packed product, place inserts into trays/carton, manually load vials into trays etc.

REQUIREMENTS

• Entry level role (0-1 years of experience)

• High School graduate or equivalent

• Manufacturing experience preferred

• Basic math skills to perform required calculations (multiplication/division).

• Good written and oral communication skills

• Good mechanical skills preferred.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Review and update assumptions used in significant estimates and accruals, prepare related journal entries and general ledger reconciliations.  This includes preparing the AP accruals, legal accruals, and Fenwal freight accrual each month. 
• Fixed Assets analysis involving medical devices returns and placements.
• Analyze and ensure assigned accounts are reconciled in accordance with the monthly close schedule and department guidelines.  Identify discrepancies, errors, and omissions and lead efforts for timely resolution.
• Maintain knowledge of U.S. GAAP, IFRS requirements, and other relevant accounting regulations in relation to relevant areas of responsibility.
• Look for operational efficiencies to current processes
• Support the North American Business Services (NAM BS) regarding Fixed Asset Accounting, roll-forwards, and reconciliations.
• Prepare schedules for year end and quarterly audits, interact with audit team to resolve open items and address audit concerns.

Job Requirements

• BA or BS in Accounting and/or Finance
• CPA or relevant work experience
• 1+ years of related accounting experience
• Excellent computer skills, including modeling in Excel and financial databases.  Knowledgeable in Project, PowerPoint, and Word.
• Working knowledge of SAP and related FI module a plus.
• Knowledge of Life Sciences industry, customer landscape and revenue processes a plus.
• Must be able to interact effectively with all levels within organization as well as with outside auditors.
• Requires interest in contracts, financial controls, and large-scale databases

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·       Supervises daily activities of scientists and technicians.  Assures that job activity deadlines are met on a timely basis.

·       Hires and oversees the training of department personnel.  Assures that steps are taken to maintain positive personnel morale and development.

·       Conducts performance evaluations.

·       Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.

·       Establishes goals for the timely release of product and performance of projects.  Monitors performance of the group against the goals to identify and implement needed corrective action.

·       Generates new/revise Standard Operating Procedures for Microbiology test procedures.

·       Ensures that raw material, component, product, or monitoring results that do not meet specifications or expectations are promptly investigated.  Identifies possible source and corrective action needed and evaluates the impact upon the product.

·       Identifies significant adverse quality trends by preparing and analyzing summary reports.  Addresses quality control test results, microbial profiles of environmental/utilities systems, and customer complaints.

·       Reviews work performed by department staff for accuracy, completeness and conformance to specifications.

·       Oversees training of departmental personnel in appropriate technique and related topics.

·       Mentors and develops new department personnel including training in Standard Operating Procedures and training checklists.

·       Assures department is equipped with functional, calibrated equipment and necessary supplies.

·       Supervises investigations of non-conforming raw material, product or components and determines disposition.

·       Works closely with Production, Quality Assurance, Chemistry, Maintenance, Metrology and Validation departments to ensure area environmental monitoring, product testing, PM, calibration and re-qualification schedules are met.

·       Supervises qualification/requalification program for production and laboratory personnel.

·       Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, EE and Investigation.

·       Ensures adequate evaluation of new product processes. 

·       Supervises validation activities for responsible area.

·       May act as a Manager in the absence of the manager.

·       Represents the department in cross functional teams and meetings.

·       Assumes other duties and responsibilities as assigned

REQUIREMENTS

·        B.S. in Microbiology or related Science with five (5) to ten (10) years of progressive pharmaceutical lab experience. 

·        Associates degree in related field with 12-15 years of progressive experience including 1-2 years of supervisory experience.

·        Equivalent combined of education and experience in pharmaceutical manufacturing, related industrial or clinical experience accepted.

·        Excellent verbal and written communication skills are essential.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Responsibilities include active partnership with others to select and manage vendors, design, select, and modify equipment and processes.
•     Repairs and maintains machinery and equipment used in the manufacturing of process utilities according to standards.
•     Checks and inspects equipment periodically to determine the need to repair or conduct preventative maintenance.
•    Carries out preventive maintenance on equipment and or systems as required by Standard Operating Procedures (SOP’s).
• Implement peripheral equipment used in the facilities and utilities process.  Supports the integration of purchased equipment during acceptance, installation, and validation. Responsible to lead other technicians to plan equipment maintenance, PMs, and performance improvements.
• Key contributor to support/ author workplace documentation.
• Identifies and implements significant continuous improvement projects on existing processes. 
• Provides leadership to enable improved manufacturing technology and process outcomes.

• Provides coverage for other mechanics and helpers as within one’s abilities, such as daily readings, changing expendable items and other tasks as requested by the maintenance supervisor.
• Uses critical thinking skills to determine possible causes of equipment failures.
• Assumes other duties and responsibilities as required.

REQUIREMENTS

• Position requires 5 or more years or relevant experience serving in a mechanic role.
• Must be an expert in the maintenance and troubleshooting of facility/utilities equipment, including a working knowledge of automated control systems boilers, HVAC system, refrigeration, compressed gases, steam and WFI generation.
• Must possess excellent documentation, communication and planning skills.
• Must be able to teach and train others.
• Must be able to work overtime as necessary.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

We offer state of the art equipment, room for growth and great benefits such as:

401(k)
Health, dental and vision insurance
Employee assistance program
Employee discount
Flexible schedule
Flexible spending account

Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Retirement plan

Tuition reimbursement
 

• Visually inspects products for various defects.

• Documents work accurately and timely.

• Complies with current SOP’s and cGMP’s.

• Sets-up, adjusts, and operates equipment such as inspection machines, cappers, etc.

• Performs and documents critical start-up procedures for filling operation such as filter integrity test, line clearance, component verification, etc.

• Performs and documents quality checks on product.

• Calculates percent defective on inspection results and reconciles components on batch record.

• Loads and unloads vials from turntables.  Stacks, wraps and moves pallets of product.

• Performs other duties as assigned.

REQUIREMENTS

• High School graduate or equivalent.

• One (1) to three (3) years’ experience preferred

• Basic math skills to perform required calculations (multiplication/division).

• Visual ability to detect defective vials.

• Good written and oral communication skills.

• Must maintain acceptable visual acuity. Must be able to maintain visual inspection qualification requirements

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

·       Be able to articulate work related issues clearly and effectively to management and peers

·       Completes testing and documents in compliance with Good Documentation Practices.

·       Maintains accurate records of all work performed

·       Completes assessment of testing results and recognizes results not meeting acceptance criteria. Promptly reports data discrepancies and out of limits conditions to supervision.

·       Carries out documentation, investigation, author incident reports, and conducts corrective actions as assigned.

·       Manages work and time based on departmental properties using own judgement and objective reasoning.

·       Performs good housekeeping practices

·       Follows safety related policies.  Makes recommendations.

·       Performs peer review of data to ensure compliance and accuracy

·       Maintains current training compliance through KabiLift

·       Assumes additional responsibilities as assigned

REQUIREMENTS

·       Bachelor of Science degree in biological sciences, or microbiology or Associates degree with 0 – 2 years of laboratory experience. 

·       Proficiency in Microsoft Office

·       Excellent verbal and written communication skills are essential.

·       Planning and organizational skills necessary for primary responsibilities.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Generates and distributes important and, at times, confidential documents (memoranda, reports, meeting minutes, general correspondence, etc.) on behalf of the Executive with minimal direction.
• Manages and processes invoices according to company guidelines. 
• Coordinates all details surrounding meetings (room, equipment, catering, etc.).
• Plans and executes team events.
• Prepares presentations and agendas for meetings as required.
• Manages the Executive’s appointment schedules by planning and scheduling meetings, conferences, special events, teleconferences, and travel. 
• Ensures security, integrity, and confidentiality of data. 
• Facilitates meeting organization and travel arrangements for the Contract Marketing & Commercial Analysis department.
• Communicates calendar changes to those affected in a timely manner. 
• Remains current regarding executive’s priorities on a daily basis. 
• Completes travel and expense reports and reconcile monthly travel card statement as necessary.
• Supports on-boarding of new hires.
• Screens and directs all telephone calls and visitors.
• Generates, maintains, and monitors the central filing system (electronic and paper filing systems) and serve as departments records coordinator.
• Assists the department as needed with a variety of areas to include, but not limited to, administration, meeting coordination, invoice processing and departmental internal communication.
• Completes all training requirements, including all department-specific, compliance training, etc.
• Ability to work flexible hours and weekends to meet business/customer needs.
• Participates in any and all reasonable work activities as assigned by management.

Requirements

• High school diploma or GED (associate degree preferred).  
• Minimum of 3-5 years’ experience in a professional, administrative support role, supporting executive management.
• Advanced computer skills (proficient with MS Office - Word, Excel, Outlook, PowerPoint, Office 365, and Internet).
• Experience  with  travel  and  expense  management  systems  required.  ERPs  (SAP  preferred)  and  other  database  concepts highly preferred.
• Excellent communication, interpersonal, and customer service skills.
• Apply advanced skills to resolve complex problems independently which may require modifying processes to resolve situations.
• Proven track record including roles of increasing responsibility.
• Effective problem-solving skills and demonstrated use of sound judgment.
• Advanced calendar management, and organizational skills.
• Excellent interpersonal and communication skills (written and verbal).
• Strong adaptability, flexibility, initiative and resourcefulness.
• Ability to exercise independent judgment and decisions.  
• Demonstrated ability to maintain a high level of professionalism and confidentiality.
• Demonstrated ability to prioritize and execute tasks in a dynamic environment.
• Ability to work independently, as well as part of a team, and handle multiple priorities with the flexibility to adjust to changing priorities and schedules.
• Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

·       Responsibilities include active partnership with others to select and manage vendors, design, select, and modify equipment and processes.

·       Implement peripheral equipment used in the manufacturing/packaging/material conveyance process.  Supports the integration of purchased equipment during acceptance, installation, and validation. Responsible to lead other technicians to plan manufacturing equipment maintenance, PMs, and performance improvements.

·       Key contributor to support/ author workplace documentation.

·       Prepares and analyzes process and equipment layouts, helps optimize staffing efficiency, material flows, and quality improvements.

·       Identifies and implements significant continuous improvement projects on existing processes.  Performs individual engineering activities as directed.

·       Provides leadership to enable improved manufacturing technology and process outcomes.

REQUIREMENTS

·       Position requires 5 or more years or relevant experience serving in a technician role.

·       Must be an expert in the maintenance and troubleshooting of production equipment, including a working knowledge of automated control systems and design of machine tooling and equipment layout.

·       Must possess excellent documentation, communication and planning skills.

·       Must be able to teach and train others.

·       Must be able to work overtime as necessary.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Summary

Responsibilities

• Data entry and processing of individual adverse event reports (Medical Device Reports – MDRs) in the vigilance database system(s), ensuring accurate electronic documentation.

• Prepares the content and integrity of the data ensuring accurate information is entered into the various database and tracking systems.

• Creates and reports on ADEs, MDRs and Field Alert Reports (FARs) to the FDA. This includes tracking, follow up and closure activities of each event, along with analyzing and evaluating for accuracy of information.

• Assists in the compiling of MedTech FDA 483 responses and monthly status reports to assist the Regulatory organization with file publishing.   

• Triages Adverse Event Reports; Retrieval of and dissemination of adverse event data from all sources to the appropriate Vigilance and/or Quality personnel.

• Assists with special projects and initiatives for the Quality Department.

• Contributes when needed to the investigation of queries relevant to medical information requests.

• Data entry and information retrieval in the KabiSafe database.

• Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.

• Additional tasks and responsibilities as required.

REQUIREMENTS:

• High School Diploma and three years of medical experience required.

• Medical Device and/or Pharmaceutical company product quality complaint and/or adverse event reporting experience preferred.

• Excellent verbal and written communication skills required.

• Ability to interface with all levels of management (in person, on the phone, and in written communications)

• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.

• Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) plus ISO 13485/MDSAP, ISO 9001, and EU MDR preferred.

• Ability to understand and interpret complex medical, clinical and adverse event data.

• Position requires a high degree of accuracy, must be able to work independently, prioritize, analyze and problem solve. Critical thinking skills are a must.

• Ability to work in a fast-paced environment and maintain internal and external compliance timelines, is required.

• Knowledge of PC systems and Microsoft Office Suite (Word, Excel, Office 365) required.

• Self-motivated and ability to work independently.

• Must be able to prioritize and multi-task with minimal supervision.

• Exceptional customer focus.

• Strong interpersonal skills and the ability to work with cross-functional teams.

• Able to effectively coordinate multiple tasks on a daily basis.

• Detail oriented with good organizational skills.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.