Specialist, Quality Assurance (Early Phase)
$67,995–$84,989 year
On-siteCosta Mesa, California, United States
Job Summary
Maintain inspection readiness and review Manufacturing Batch Production Records, forms, and testing documentation from Microbiology and Chemistry groups. Assist in API batch releases, discrepancy investigations, and excursion reports while compiling QA reviews of batch history records. Serve as a technical subject matter expert on cross-functional and multi-site teams, identifying procedure gaps and collaborating to establish targets and timelines. Provide Quality oversight to internal and external customers by interacting with interdepartmental contacts on assessment and resolution, ensuring all activities execute efficiently per governing SOPs. Generate departmental performance metrics and sign documents as authorized per company policies.
Required Qualifications
- B.A. or B.S. degree (preferably in the life science disciplines)
- At least 2 years of experience in the biopharmaceutical industry
- Knowledge of cGMPs or equivalent regulations
- Ability to interpret quality standards for implementation
- Skills to independently evaluate situations and propose potential solutions
- Ability to work overtime and/or weekends when necessary
- Full-time onsite position
- Monday through Friday work schedule
- Visual acuity, including close, distance, and color vision
Desired Qualifications
- B.A. or B.S. degree (preferably in the life science disciplines)
- Ability to work overtime and/or weekends when necessary
- Full-time onsite position
- Monday through Friday work schedule
- Visual acuity, including close, distance, and color vision
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