Manager, Quality Control (Microbiology Emphasis)

The Manager, Quality Control (QC) with an emphasis in microbiology provides microbiological understanding and oversight for the safe and effective processing of radiopharmaceutical drugs used to diagnose and treat diseases. The Manager, QC will provide quality control oversight and direction from incoming material inspection and through product release. Projects and duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other applicable regulatory agencies standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Review and approve documents in support of any microbiological testing/data performed or generated.
2. Hire, manage, and develop QC personnel to ensure compliance with the applicable regulations.
3. Liaise with Microbiologists and QC personnel at other sites – Columbia, Femrite, and Progress to ensure consistent application of microbiology methods and procedures for GMP laboratory testing.
4. Prepare and provide monthly QC quality performance metrics to the department Senior Management.
5. Conduct standard microbiological tasks (e.g. identification of microbial agents, preparation of growth media, growth promotion tests, maintenance of microbial cultures, etc.).
6. Conduct tests on radiopharmaceutical manufacturing processes to assess microbiological impact.
7. Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards of the US FDA, 21 CFR Part 210 & 211.
8. Execute internal and external audits as needed.
9. Assist in the creation of Standard Operating Procedures, protocols, and reports.
10. Develop and validate laboratory procedures within the department and comply with cGMP in all areas of the business.
11. Environmental monitoring of classified cleanrooms.
12. Support dose audit program.
13. Use of standard microbiology laboratory equipment.
14. Bioburden, Sterility, and Bacterial Endotoxin Test (BET) analyses for process samples, including radioactive samples.
15. Sampling and analysis of Water for Injection, Purified water, and pure steam condensate; including reparation of trends for environmental monitoring and water.
16. Operation of steam sterilizer (autoclave) and dry heat sterilizer (oven).
17. Estimation of total organic carbon from water samples and cleaning samples.
18. Maintain and update laboratory databases track and trend data.
19. Provide management with regular progress reports of tests.
20. Perform other quality assurance functions as necessary, with appropriate training.
21. Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
22. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.

Ability and willingness to travel up to _20_% of the time between facilities.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s Degree in Microbiology, Biology or other related scientific discipline and eight or more years of progressive experience in the medical device or pharmaceutical industry and a minimum of four years of management experience; or equivalent combination of education and experience. Experience working directly with regulatory agencies, sound knowledge of applicable portions of agency guidance, and regulations (21CFR Part 210/211/820 and ISO 13485).

Experience with Microsoft Office software programs, including Outlook, Word, and Excel.

Provide an interactive, problem solving environment to address any weaknesses within the team. Responsibilities include: interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Detail oriented and very organized
• Strong verbal and written communication skills
• Ability to prioritize and handle multiple tasks simultaneously
• Adaptable to change in the work environment
• Ability to work in a fast-paced environment
• Ability to work in a team environment, as well as independently

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.



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