Quality Assurance Associate, Biopharma Medical Device (JP9524)
3 Key Consulting•Thousand Oaks, CA
•Onsite
About The Position
This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function.
Requirements
- Quality assurance or manufacturing experience in the pharmaceutical or medical device industry
- Experience with GMP processes and documentation
- Ability to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness
- Ability to work in a team with shifting priorities and shifting responsibilities, such that the team members must be confident verbal communicators able to discuss responsibilities, divide them, reassess them, and potentially reassign them throughout the day or week
- 1 + GMP processes and documentation experience
- Good Manufacturing practices
- Inspection and QA background
- Attention to detail; assign expiration dates on labels, providing info on labels, and documentation
Nice To Haves
- Packaging experience
Responsibilities
- Review and approval of printed clinical labels
- Finished clinical pack inspection
- Expiration date calculation
- Batch record review
- Generation and compilation of quality data and reports (e.g. lot track/trace, deviations)
- Assist with procedure reviews
- Initiation of deviation reports
- Potential for role expansion into support of a product distribution function
Benefits
- Good team atmosphere and supportive team
- Opportunity to learn and grow
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What This Job Offers
Career Level
Entry Level
Education Level
No Education Listed
