Total 6 Quality Assurance / Control job vacancies in Calumet, Michigan

This is not a remote work position. The selectee will report to an assigned DOL office location on a regular basis and is eligible for participation in telework as determined by management in accordance with DOL policy.

Major Duties:

• This position is established as District Director (DD).
• Responsible for planning, prioritizing, directing, and assigning work, collaborating with peers and subordinates, including all fiduciary responsibilities, to achieve OFCCP's mission.
• Schedules compliance reviews within the District Office's (DO) jurisdiction. Investigates and resolves discrimination complaints, closes complaints where no basis is found, and seeks appropriate resolution when applicable.
• Recommends the issuance of show cause notices when applicable.
• Develops cases for which administrative and/or judicial actions are appropriate and recommends these actions to the Regional Director (RD) for disposition.
• Analyzes affirmative action plans submitted by contractors, including the establishment of linkage agreements.
• Monitors contractors' conciliation agreements, progress notes, and consent decrees.
• Conducts detailed and comprehensive analyses of federal contractors' total employment procedures and practices to determine responsiveness to federal procurement and equal employment opportunity (EEO) laws, executive orders, policies, rules, and regulations.
• Identifies discrimination based on evaluation and investigatory activity.
• Manages the efforts of a staff of supervisors and compliance investigators and maximizes their utilization through effective work assignments.

***THIS IS A TITLE 5 EXCEPTED NATIONAL GUARD POSITION***
This position is located in an Army National Guard (ARNG) Air Traffic Control Tower. The primary purpose of this position is to provide tower Air Traffic Control (ATC) services to military and civilian aircraft operating under Instrument Flight Rules (IFR) and Visual Flight Rules (VFR). Incumbent also functions as an ATC Specialist/ATC Training Specialist with responsibility for guiding and training for Air Traffic Controller trainees.

DUTIES
1. Performs air traffic control duties in the control tower. Directs movement of aircraft in flight and on the ground by utilizing pilot and controller reports, visual observation, and/or tower displays, or a combination of methods and in close coordination with other controllers. under restrictive time and space limitations, formulates and issues ATC clearances and instructions to provide for the required separation and or sequencing of all IFR and VFR traffic within delegated airspace.

2. Executes the standardized ATC training program in accordance with guidelines established by regulations of the Department of Army (DA), Department of Defense (DoD), and Federal Aviation Administration (FAA). Incumbent is responsible for the utilization of training materials that ensure controller-trainees are adequately trained and tested with the goal of creating a cohesive ATC team that provides multi-level ATC services to the aviation customer. Incumbent ensures all newly assigned trainees receive training in accordance with applicable regulations.

3. Operates, trains, and provides preventative maintenance on a host of automated communications and display hardware and software systems that are integral and vital to the operation of the air traffic control facility. Maintains communications with aircraft and adjacent facilities to transmit and receive instructions and information relative to flight.

4. Evaluates weather reports from automated (ASOS, AWADS, IDS, etc.) or other sources (i.e. Pilot Reports) and ensures weather information is accurate, specific, and timely. Modifies, corrects, or augments as appropriate for official weather reporting. Provides dissemination of weather warnings, Center Weather Advisories (CWA), Significant Meteorological Information (SIGMET), or Meteorological Information (MET) watch advisories.

5. Conducts and directs aircraft mishap and hazardous air traffic systems reporting. Serves as the focal point on the airfield for ground or airborne aircraft mishaps, system reports on hazardous air traffic activities, and ATC and pilot incident inquiries.

• Assist in conducting meetings, briefings, training sessions, or conferences to express quality assurance issues or concepts in a clear, concise and convincing manner.
• Convey quality assurance information using a variety of written formats and techniques to audiences with a varying level of knowledge on the subject.
• Assist in identifying for corrective action deficiencies caused by improper storage methods, extended periods of storage, or inherent deterioration characteristics of the material.
• Assist in reading, interpreting and applying technical data such as blueprints, engineering drawings, product specifications, and/or technical manuals.
• Assist in identifying inadequacies and recommending corrective action.
• Assist in verifying that products comply with requirements prior to acceptance.
• Assist in verifying product quality using sampling inspection or, when appropriate to the characteristics involved or pertinent quality history, more intensive product inspection techniques.

***THIS IS A TITLE 32 NATIONAL GUARD POISITION THAT REQUIRES MILITARY MEMBERSHIP***

This position is located at an Air National Guard Air Operations Group. Its paramount purpose is to monitor and oversee the planning, organization, and supervision of all unit programs required by Air Force, Major Command, and ANG regulations in the training and employment of the force level Air Operations Center (AOC) weapons system. The Operations Director must ensure AOC weapons systems personnel are capable of operating in a United States-only, North Atlantic Treaty Organization (NATO), or a tailored alliance environment. In addition to supervisory responsibility, the incumbent possesses rated or air battle management experience and maintains AOC positional certification.

This position requires military membership. It is designated for National Guard officer incumbency only. The incumbent provides supervision, subordinate guidance and team leadership to NDS and DS employees. Incumbent performs long-term planning and organizational development necessary accomplish aerospace warfare training functions in support of programs essential to state Air National Guard daily operations, training, and readiness missions. Fosters an environment conductive to teaming among service providers and customers to meet state Air/Army National Guard requirements.

1. Plans work to be accomplished by the organization which consists of full-time subordinates engaged in technical and administrative work.

2. Oversees all unit operations activities which based on unit mission and equipment may include any of the following theater level Air Operations program support functional areas: Combat Operations, Combat Plans, and Training/Evaluation, Weapons and Tactics, and Scheduling.

3. Develops long-range training and deployment plans for the unit to meet training goals, higher headquarters inspection schedules and overseas deployment requirements.

4. Serves as a Senior Operations advisor on the Commander's staff to coordinate operational exercises and contingency taskings.

5. Serves as the Operations representative on the Commander's Financial Management Board.

6. Develops and directs the force level weapons system implementation program in coordination with higher headquarters to meet approved employment concepts.

7. Oversees training of all assigned/attached AOC positionally assigned battle rostered personnel.

8. Monitors the implementation of an effective division safety program for all operations and related ground activities.

9. Develops division policy for fight management personnel to ensure effective and efficient administrative control of all flight documentation and individual flight records.

10. Must maintain positional certification and meet requirements as prescribed by applicable regulations and directives.

***THIS IS A TITLE 5 EXCEPTED NATIONAL GUARD POSITION***

The primary purpose of this position is: To perform fire prevention and inspection duties designed to detect and reduce or eliminate fire hazards in a high fire expectancy area. Develops and conducts extensive fire protection and prevention education and training programs.

1. Conducts an information program to elicit support and involvement in fire prevention, detection, and suppression. Secures client interest through emphasis of pertinent fire prevention topics and developing messages from actual fire incidents.

2. Performs regular and periodic fire protection inspections for all areas of the installation where the potential severity and expectancy for fire is high and involves hazards that are difficult to recognize and, once identified, require advanced or innovative methods to reduce or eliminate them. Adapts accepted techniques for application to potential hazards in highly specialized and technical operations.

3. Inspects, tests, and corrects deficiencies on a variety of fire protection systems, many of which are complex or designed for a specific operation or hazardous condition, (e.g., carbon dioxide cascade systems, halon total flood systems, heat rise detection systems, and interlock systems).Maintains close checks on new systems being installed to ensure installation and performance are in accordance with established standards.

4. Reviews engineering plans and specifications for new construction, alteration, and extension of existing structures. Recommends changes and additions to ensure plans include appropriate fire protection requirements as called for in agency regulations, National Fire Protection Association(NFPA) building codes, and other applicable guidelines.

5. Develops and maintains a variety of documentation such as fire prevention inspection schedules and facilities jackets on assigned facilities. Jackets include information on hazards, pre-fire plans, risk assessment codes (RAC), and regularly scheduled and special inspections conducted.

6. Complies with health, safety, and environmental rules and procedures and performs work in a manner that enhances the safety of the work environment. Ensures federal, state, and local protection/prevention ordinances and building codes concerning health, safety, and the environment are strictly adhered to.

The Manager, Quality Control Lab is responsible for overseeing day-to-day operations of the QC Lab group. Position will supervise and enforce cGMPs, GLPs, conducting investigations, methods transfer, verification of compendia methods, and training/coaching of new employees.

QC Lab management mainly for a single site.  Position may have up to 8 direct reports.

• Manage day-to-day operations of assigned section of QC laboratory.
• Schedule laboratory analyses for testing for commercial and R&D purposes.  Release test results to QA or other departments in a timely manner.
• Understand analytical instrument operation and maintenance. Troubleshoot instrument problems for chemists and supervisors.           
• Review chemist notebooks and instrument logbooks on regular basis. Review/approve validation protocol, report, and SQARs for raw material testing in a timely manner.
• Review/comment on articles affecting QC in USP Supplements and Pharmacopeial Forums. 
• Coordinate/assist R&D lab in method transfer, verification and validation activities. 
• Oversee the control and management of controlled substances. 

Documentation Practice, Training & Compliance

• Monitor implementation of good documentation practice per company's SOP and cGMP regulation in the laboratory.  
• Prepare, review or approve laboratory documents such as Laboratory Deviation, Test Method, Deviation Report and SOP in a timely manner.
• Monitor implementation of all applicable safety and standards guidelines, DEA regulations and /or MSDS in the laboratory.    
• Provide chemists and supervisors with training in SOPs, analytical instrument, cGMP and other regulations.  Develop, monitor and improve training system. 
• Prepare chemists, supervisor and laboratory for FDA and other compliance audits.
• Periodically review USP, EP and JP monographs; update internal testing procedures accordingly.
• Represent QC lab to attend inter-departmental meetings.

Lab Maintenance

• Develop/monitor/improve: 1) lab instrument maint./calibration system; 2) sample, standard and chemical inventory and receiving system; 3) lab document filing system.
• Enforce wearing of laboratory coat and safety glasses while working in lab.
• Oversee ordering of lab supplies.
• Ensure lab area is clean; monitor expiration dates of all reagents and solutions.
• Monitor the overall laboratory productivity and efficiency.

Staff Development

• Evaluate potential candidates for QC and prepare annual performance evaluations to supervisors and chemists.

Qualifications

Education & Experience

• BS in chemistry, biochemistry, pharmacy or related discipline.  Advanced degree a plus.
• 10+ years’ experience in pharmaceutical lab, particularly in appropriate area of specialty.
• 3+ years of supervisory experience.

Knowledge

• Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
• Strong knowledge/proficiency required with lab techniques/instruments: microbiological testing, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, HPLC or GC and analytical balance, etc.

Skills & Abilities

• Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.
• Technical Skills - Assesses own strengths and weaknesses; pursues training and development opportunities; strives to continuously build knowledge and skills; shares expertise with others.
• Customer Service - Manages difficult, emotional customer situations; responds promptly; solicits feedback to improve service; responds to requests for service and assistance; meets commitments.
• Quality Mgt - Looks for ways to improve/promote quality; demonstrates accuracy/thoroughness.
• Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
• Safety and Security - Observes safety/security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions; uses equipment/materials properly.
• Excellent written and oral communication skills.
• Treats people with respect and fairness.
• Good management and leadership skills with strong interpersonal and influencing skills.
• Flexibility in carrying out various assignments. 

Physical Requirements

Physical & mental requirements    

• Extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some bus. travel.  Work is in a FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.
• Must occasionally lift and/or move up to 25 lbs. Lab coat and safety glasses required. 
• Specific visions abilities are required by this job include close vision and color vision.
• The noise level in the work environment is usually moderate. 
• The work environment is representative of a group laboratory environment.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.