South San Francisco, CA
Contract to Hire
The ideal candidate is an experienced QA Specialist with a track record of success in GMP environments and understands biologics processes (i.e. fermentation, aseptic environments, reagent control, contamination control). The job incumbent will be responsible for the following in support of QA activities:
- Draft and revise standard operating procedures (SOPs) to support PACT's Quality System
- Review validation protocols, executed validation studies and validation summary reports as needed to support GMP activities
- Review investigations for manufacturing, quality control and other GMP systems for completeness and tracking. Suggest improvements to program based on trending or observations.
- Review and approve raw materials, manufacturing components, and product containers for use in manufacturing
- Approve preparation of routine batch production paperwork including lot numbers, batch records, labels, forms etc.
- Review completed batch records and testing in support of product relase activities
- Review change control and documents as needed
- Review calibration certificates
- Provide training and guidance on Quality Assurance topics to foster a quality culture and quality mindset
- Perform compliance review of internal controls and procedures in PACT's Quality System and ensure alignment with current regulatory requirements
- Prepare Quality metrics to show the health of PACT's Quality System and make recommendations/improvements in policies and procedures
- Other functions as necessary for QA under management's discretion and in support of QA systems
- Must have thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint. Excellent verbal and written communication skills.
- Ability to build strong working relationships with multiple departments
- Ideal candidate holds a bachelor's degree or higher in relevant biological science
- The role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives
- Must have worked for 5+ years in industry with GMP quality assurance experience in a similar environment