logo

View all jobs

Associate Quality Assurance

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                
  • 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
  • Packaging experience, is preferred
Day to Day Responsibilities:            
  • 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 also the potential for role expansion into support of a product distribution function.
Summary
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. Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry

Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. Must be able 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. Must be able 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.

"This posting is for Contingent Worker, not an FTE"

More Openings

.NET Programmer
IT Project Manager
Project Manager

Share This Job

Powered by