Quality Assurance Associate Job

Company Name:
Salary period: Annual
Senior Quality Assurance Associate needed for a contract opportunity with Yoh's client located in Thousand Oaks, CA.
The Big Picture:
Quality Assurance provides quality and compliance oversight of the manufacturing plant for the Drug Substance and Drug Substance Intermediate stages. This includes, cell culture, and purification processes as well as plant support functions such as maintenance, metrology, engineering, and automation.
What You'll Be Doing:
- Grave shift - must be able to work grave shift, shifts may change; person must be flexible to shift changes.
- Provide Quality Assurance oversight for manufacturing and support operations for biopharmaceutical products.
- Ensure compliance to GMP regulations for area operations and associated or support processes.
- Support investigations/deviation reports (nonconformance reports).
- Management of GMP documentation, including Real Time manufacturing document review, approval, and archiving.
- QA contact or approver Class 1 Nonconformances.
- Provide plant floor Quality oversight to maintain an inspection ready facility as part of 75% required time on the manufacturing floor.
- May be asked to give additional assistance to management within the Quality Assurance group as needed. For example, metrics compilation or data gathering, project support, etc.
What You Need to Bring to the Table:
- Bachelor's Degree in Biochemistry, Biology, Chemistry or related science field
- Previous experience in Amgen's quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo)
- Demonstrated science based approach and ability to deliver results
- Experience working in multiple GMP databases
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
- Experience in reviewing and approval of batch records, NC/CAPA's and Change Control records
- 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 technical written communication skills, strong interpersonal skills to ie articulate quality requirements and rationale to others
- Knowledgeable of regulatory requirements/Quality Principles
- Able to effectively handle and operate in a rapidly changing environment
- Strong team player
- Complex decision making skills and ability to complete tasks autonomously, provide updates to area manager, and identify potential issues
What are you waiting for? Apply Now!
Recruiter: Joan Lowery
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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