QA Senior Associate

Our client is looking for a QA Senior Associate for an 11+ month position in Thousand Oaks, CA.

Provide swing shift (1:30-10:30 PM or later) Quality Assurance oversight for bulk manufacturing operations for clinical biopharmaceutical products. Shift may change based upon need.

Ensure compliance to GMP regulations for area operations and associated processes.

Typical tasks include:
• Support investigations/deviation reports (nonconformance reports)
• Management of GMP documentation, including real time manufacturing document review, approval, and archiving
• Provide plant floor Quality oversight to maintain an inspection ready facility as part of 75% time on the manufacturing floor

This position requires effective communication, ability to work well in teams, demonstrated science based approach and ability to deliver results.

The successful candidate will have experience working in multiple GMP databases

• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
• Bachelor’s Degree in Biochemistry, Biology, Chemistry or related science field with 2 years of experience in GMP/GCP operations or similarly regulated industry
• Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation
• Ability to focus on detail and ensure accuracy of execution tasks, documentation per GMP standards
• Effective verbal and written communication skills, strong interpersonal skills
• Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues



Preferred Qualifications
• 3+ years of experience in a Quality Assurance or related role, ie, supporting GMP functions such as Non Conformance root cause analysis.
• Previous experience in quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ)
• Strong technical writing skills, demonstrated experience creating deviation technical assessments or equivalent