Total 3 job vacancies by 225 Cardinal Health 414, LLC

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Responsibilities

• Quality Assurance responsibilities include, but are not limited to, cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
• Establish and report metrics related products and processes.
• Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting requirements.
• Champion Quality, cGMP compliance, and EHS/Radiation Safety practices.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Assures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
• Understands technical/release product issues and evaluates their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the cGMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s of Science preferred – Chemistry degree highly preferred or equivalent work experience preferred
• 2+ years’ experience in a regulated environment preferred, pharmaceutical experience preferred.
• Possess an understanding of cGMP/compliance requirements for 210/211 preferred.
• Strong attention to detail.
• Ability to manage timelines and priorities.
• Ability to work independently with minimum guidance.
• Ability to multi-task.

Schedule

• Onsite in Aurora, CO. Typically, Monday-Friday between 8:00 am-5:00 pm. Candidate must be available to work weekends to provide coverage at site. Weekend work will be limited.

Physical/ Mental Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds.

Work Environment

• The primary work environment consists of an office, warehouse, and production environments within a radiopharmaceutical manufacturing facility. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards.  The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $74,500-$106,400

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 05/11/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring. 

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
• Engages and collaborates with operations department to drive quality system and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Monitors CAPA in investigations and closes when completed or escalates (if necessary).
• Performs aseptic review of the site with operations and documents results.
• Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Schedule:  Onsite in Denver, CO. 40 hours per week.  This is a night position.  Typically, Monday - Friday 1:30 am – 10:00 am.  Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day.  Work hours may be subject to change.

Qualifications

• Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred
• 2+ years of experience in related science field preferred
• 1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP
• Pharmaceutical or medical device experience a plus
• Effective written and verbal English communication skills
• ISO experience a plus
• Ability to lift between 30-45 lbs.
• Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
• Understanding of the requirements and can perform gap assessments to those requirements, a plus
• Ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus
• Understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving, a plus

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $74,500-$106,400

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/08/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary
The Principal Specialist, Quality Assurance is responsible for ensuring quality standards and procedures are followed. They will be in charge of quality monitoring and assurance to ensure that all products manufactured are of the highest quality possible. Inspection and quality assurance activities to meet specifications and quality standards for variety of in-process and finished products. Authorized to inspect products to ensure the required quality standards are met. Reports to Manager, Quality Assurance.

Responsibilities

• Inspecting and sampling of product throughout the manufacturing process.
•  Establish and maintain quality control procedures.
• Assist in determining types of tests to be performed as well as documentation and reporting
• requirements.
• Interact regularly with manufacturing and service functions to establish quality standards for raw material, work in process, and finished products.
• Champion Quality, GMP compliance and EHS/Radiation Safety practices.
• Develop and lead GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems.
• Assists in the release of the final product in compliance with applicable regulations (FDA, EU,
• etc.) and marketing authorizations.
• Responsible for the review and dispositioning of incoming raw materials and components.
• Ensures quality events are complete and accurate and resolved in a timely manner that meets the expectations of applicable quality agreements.
• Responsible for approval of minor Quality Events.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting.  In that context, has the knowledge of the production process of the product.
• Understands technical/release product issues and evaluate their potential impact on product quality and compliance.
• Provides ideas for continuous improvement of the GMP Quality Management System.
• Escalates complex issues to management in a timely manner.
• Prioritizes and ensures work is delivered in an efficient way.
• Performs other job duties as assigned.

Qualifications

• Bachelor’s degree in a scientific field preferred or previous work experience in a similar role or related field preferred
• 4-8 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred.
• Strong attention to detail
• Ability to multi-task and manage timelines and priorities.
• Ability to work independently with minimum guidance.

Location

• Onsite in Indianapolis, IN

Physical/ Mental Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl; talk or hear; and taste or smell. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Work Environment

• The primary work environment consists of an office, warehouse and production environments within a radiopharmaceutical manufacturing facility. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
• May contribute to the development of policies and procedures
• Works on complex projects of large scope
• Develops technical solutions to a wide range of difficult problems
• Solutions are innovative and consistent with organization objectives
• Completes work; independently receives general guidance on new projects
• Work reviewed for purpose of meeting objectives
• May act as a mentor to less experienced colleagues

Anticipated salary range: $78,500-$112,100

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/14/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here