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Supervisor Lab Services - Quality Cont

Job in Irvine - Orange County - CA California - USA , 92606
Company: NAMSA
Contract position
Listed on 2021-02-24
Job specializations:
  • Science
  • Research/Development
Job Description & How to Apply Below
NAMSA pioneered the industry, NAMSA 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 whose:

* Mission is to make a scientific contribution to every medical device in the world.
* Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
* Values have stood the test of time.
* Above all else, conduct ourselves with integrity

Job Description:

Principal Duties and Responsibilities

* Responsible for supervising staff and overseeing overall day-to-day activities.
* May advise clients on routine technical issues and participate in client meetings.
* Raw data review including analysis and interpretation of data.
* Report writing, review and approval.
* Test specification, raw material, and protocol generation, review and approval.
* Generation, review and approval of all non-routine worksheets.
* May assist with Cost Estimate Proposals.
* Assists with monitoring variances, failures and non-conformances and handling all complaints in a timely manner.
* Controls expenses by submitting budget information and scheduling expenditures.
* Ensure compliance with current Good Manufacturing Practice regulations, and other associated guidance such as AAMI, ANSI, ISO and USP.
* May perform other related duties as assigned.

Qualifications and Skills

* 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 LAL testing and GMP a MUST
* Experience with regulatory interface preferred.
* Fluency in English and local language, if different, required.

Technical Competencies

* 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.

Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed.
Position Requirements
Less than 1 Year work experience
 
 
 
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