Senior Associate Quality Assurance / Aseptic Coach
$82,081–$111,052 year
On-siteThousand Oaks, California, United States
Thousand Oaks, California, United StatesOn-siteFull Time$82,081–$111,052 yearSenior LevelEnterprise
Full TimeSenior LevelEnterprise
Job Summary
Conduct daily oversight of Drug Product manufacturing areas, providing real-time aseptic coaching and troubleshooting for filling activities in a 24/7 Grade 8 facility. Perform 100% manual visual inspection support, review electronic batch records, and approve GMP documents including SOPs, FORMs, and maintenance work orders. Manage quality-related decision making for non-routine interventions and minor deviations while ensuring process execution aligns with regulatory requirements. Support predominantly second and third shifts, including weekends, with rotations ranging from 8 to 12 hours.
Required Qualifications
- High school/GED + 4 years of GMP experience
- Associate's + 2 years of GMP experience
- Bachelor's + 6 months of GMP experience
- Must be flexible with shift work (including weekends)
- Comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility
- Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)
- Shift rotations will be required (Days, Swings, Graves) to support production schedule
Desired Qualifications
- Master's Preferred
- Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
- Experience managing projects through to completion meeting timelines
- Ability to evaluate documentation and operations according to company procedures
- Experience working with Quality Systems
- Strong organizational skills and ability to manage multiple tasks at one time
- Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives
- Solid understanding and application of aseptic behaviors and principles
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