QA Specialist Job Responsibilities
Education & Qualifications
- Perform QA review of the client's production records and other documentation associated with production and release of Biological products per QA SOPs
- Receive, control, scan and archive of completed client's manufacturing production records
- Update QA databases for batch record review status
- Prepare and compile batch record lot history files for Cell Culture or Formulated bulk drug substance (FBDS) lots.
- Interact with Manufacturing personnel
- Expected to exercise some independent judgment within the job responsibilities and perform the job responsibilities with minimum supervision.
- Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.
- Other QALR duties as assigned.
- Bachelor of Science degree in Biology, Biochemistry, Chemistry, Chemical Engineering or related field.
- 2 years relevant experience
- Working knowledge of desktop computers (ie: Excel, Microsoft Word).
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.