Senior Associate - Quality Assurance Job

Yoh has a contract opportunity for SENIOR ASSOCIATE - QUALITY ASSURANCE to join our client in Thousand Oaks, CA.

Job Responsibilities:

- Provide grave shift (11PM to 7:30AM or other) Quality Assurance oversight for bulk manufacturing operations for biopharmaceutical products. Shift may change based upon need.
- Ensure compliance to GMP regulations for area operations and associated processes.
- 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.

Job Qualifications:

- Bachelor's Degree in Biochemistry, Biology, Chemistry or related science field with two (2) years of experience in GMP/GCP operations or similarly regulated industry
- 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.
- 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
- Three (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

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Salima Hakim

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

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SFSF: LS