Quality Control | Santa Ana | CA
We are hiring for a Quality Control (QC) Supervisor. The QC Supervisor oversees the testing and inspection of products, processes, raw materials and WIP to ensure compliance with appropriate specifications.
- Provide work direction to and supervision of the QC staff
- Organize for and maintain orderly flow of required testing, including notification of progress to all affected departments in a timely manner
- Modify and improve existing test methodologies and/or develop new test protocols as needed to maintain state of the art testing methodologies
- Develop raw material and product specifications as needed
- Develop and maintain appropriate product retention and stability dating programs
- Monitor and maintain QC Laboratory equipment and process validation status
- Provide for environmental monitoring of required areas; trend analysis of data; report variances with recommended solutions
- Assists in activities related to the preparation for and conduct of FDA, Notified Body inspections, and customer audits
- Track, record, and trend out of specifications
- BS/BA in Microbiology, Biology or Chemistry; advanced study in Microbiology is highly desirable
- 3 or more years of biological or microbiological laboratory experience
- Good skills in tissue culture, biochemical, and microbiological testing methodologies
- Demonstrated supervisory skills
- Detailed understanding of 21 CFR Part 211, 21 CFR Part 820, ISO 13485, Canadian MDR, MDD 93/42 with emphasis on laboratory testing, material specifications, and related areas
Principals only. No recruiters please.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.