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Quality Control Laboratory Manager

4 months ago

Cumberland, United States Tedor Pharma Services Full time

Quality Control Laboratory Manager


Position Summary:

The Quality Control Laboratory Manager will be responsible for method validation, product release, raw material release, and stability testing for clinical trial material and commercial drug products. They are responsible for leading a team and managing a lab that verifys all products and/or substances meet acceptable quality standards and that they are in accordance with the company’s policies & procedures, FDA policies and procedures, and any applicable cGMP requirements.


The manager will be in charge of all laboratory equipment and MUST have experience with HPLC's and 10 years or more in wet chemistry in the pharmaceutical industry.


Additionally, ensuring compliance, accuracy, and timeliness of specified testing processes, environmental monitoring, data review, data analysis, and data trending of all raw materials, finished formulations, stability samples, client-based & company-based projects, method development, equipment calibrations/qualification and/or transfers, and cleaning study qualifications are all essential responsibilities to supervise and collaborate with QC Analysts and Development Chemists while performing this position. 


This is a full-time, non-exempt position that includes a competitive salary and strong benefits. The Quality Control Laboratory Manager will report indirectly to the Site Head / Plant Manager.


Position Description:

Responsibilities

  1. Head the collaboration between QC and Developmental Chemists personnel but also cross department collaboration regarding drug product development, commercial operations, commercial manufacturing, Quality Assurance, and Analytical Development.
  2. Initial evaluation of QC laboratory including operational execution and resources.
  3. Ability to identify, hire, train, and consistently coach staff while leading/developing managers.
  4. Generate, review and revise QC GMP documentation (SOPs, protocols, technical reports, specifications, etc.).
  5. Revise and manage technical transfer of methods from internal labs for raw material analysis, in-process testing, as well as API and Drug Product testing.
  6. Review and report all QC data and generate Certificates of Analysis. Monitor and trend QC data generated by internal and contract testing labs.
  7. Initiate ICH stability study protocols, execute and generate of interim reports.
  8. Manage, write, and review Out of Specification/Atypical results/Out of Trend investigations, deviations, and CAPAs.
  9. Investigate and troubleshoot method issues.
  10. Communicate budget, project requirements and issues to Management.
  11. Oversee and manage contract testing labs.
  12. Review relevant sections of regulatory filings.
  13. Ability to assess staffing needs and maximize QC efficiency and productivity.
  14. Monitor calibration schedule.
  15. Negotiate quotes.
  16. Contact vendors.
  17. Schedule visits for PM/Calib and repairs.
  18. Assist vendors on site.
  19. Coordinate stability operation activities and ensure quality products and systems.
  20. Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols.
  21. Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications.
  22. Prepare stability data graphs to estimate expiration dates and verify product shelf life.
  23. Evaluate stability trends and prepare reports.
  24. Equipment Qualification, including data integrity program.


Position Type & Expected Hours of Work

This is a full-time, non-exempt position requiring a minimum of 40 hours of work per week, Monday through Friday. Some responsibilities may require work outside of normal office hours. 

Work Environment

Level 2: Office Environment and Laboratory Environment

The work environment characteristics described here are representative of those a teammate encounters while performing the essential functions of this role and within the daily operations of a professional office environment. Reasonable accommodations may be made to enable employees with disabilities to perform essential functions. 

This job operates in a professional office environment, as well as the laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as standard laboratory equipment and instrumentation. An employee in this role will be exposed to standard hazards founds within a laboratory environment such as chemicals; bloodborne pathogens; fumes; select agents; confined spaces. Proper laboratory attire and safety gear such as protective eyewear; laboratory coat; appropriate gloves must be observed.

Physical Demands

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. 

This role requires standard physical demands within a standard office and laboratory environment where sustained periods of standing, sitting, or walking will be part of an employee’s daily routine, whether they are at their desk or in the laboratory. While performing the duties of this role, an employee is regularly required to talk or hear; use hands or fingers to handle or feel; reach with arms; bend or stoop; climb stairs; crawl or crouch; kneel; push or pull; type on a keyboard; use a computer mouse. Lastly, an employee must be able to lift ten (10) pounds.

Travel

No travel is expected for this position.


Required Education & Experience

  1. B.S. in Chemistry or Pharmaceutical Science, or other related discipline such as life sciences, drug product development.
  2. Five to Seven (5 – 7) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC) as a manager or supervisor
  3. 10 + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products. HPLC experience a must.
  4. Experience in QC testing of pharmaceutical and/or biologic products in a GMP environment.
  5. Solid understanding of GMP compliance, Quality Control CMC requirements for ANDAs, and other regulatory filings
  6. Excellent interpersonal, verbal, and written communication skills
  7. Demonstrated collaborative skills and prior leadership roles or positions
  8. Comfortable in a fast-paced, small company environment, ability to adjust workload based upon changing priorities
  9. Strong technical knowledge
  10. Strong Microsoft Word, Excel, and Office skills
  11. Experience in managing contracting testing laboratories

Preferred Experience & Experience

  1. MS in relevant life science, scientific, or engineering discipline
  2. Seven to Ten (7 – 10) years of work/laboratory experience in the pharmaceutical industry, Quality Control (QC), as a manager or supervisor
  3. 15 + years of experience in a regulated manufacturing or QC laboratory environment of analytical methods for pharmaceutical products

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. All duties, responsibilities, and activities may be subject to change at any time with or without notice.