Supervisor Lab Services - Sterility Assurance (Bioburden) (Finance)
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
- Act with integrity in everything we do.
- Provide best-in-class customer experiences.
- Develop superior talent and deliver expertise.
- Respond with agility and provide timely results.
- Embrace collaboration, diverse perspectives and ideas.
Job Description:
• \tResponsible for supervising staff and overseeing overall day-to-day activities.
• \tMay advise clients on routine technical issues and participate in client meetings.
• \tRaw data review including analysis and interpretation of data.
• \tReport writing, review and approval.
• \tTest specification, raw material, and protocol generation, review and approval.
• \tGeneration, review and approval of all non-routine worksheets.
• \tMay assist with Cost Estimate Proposals.
• \tAssists with monitoring variances, failures and non-conformances and handling all complaints in a timely manner.
• \tControls expenses by submitting budget information and scheduling expenditures.
• \tEnsure compliance with current Good Manufacturing Practice regulations, and other associated guidance such as AAMI, ANSI, ISO and USP.
• \tMay perform other related duties as assigned.
Qualifications & Technical Competencies:
• Requires a Bachelor's degree in Microbiology/Biology, Chemistry or related scientific discipline.
• Requires 5 years related laboratory experience and at least 1 year in a leadership role.
• Experience with regulatory interface preferred.
• Fluency in English and local language, if different, required.
• NAMSA client communication training may be required.
• Familiarity with medical device industry and regulatory compliance issues (ISO, FDA/QSR, GMA, and AAMI).
• Understanding of the Scientific Methodology and technique/procedures involved in principal duties.
Working Conditions:
• Physical activities include walking, standing, or sitting for prolonged periods and operating laboratory equipment.
• Extensive use of computer keyboard and mouse.
