Job description

***Must have Biotech/ Pharma experience required***

candidates start off on an 8am to 5pm M-F for ~4-5 weeks until they get there access to the plant and have read there SOP's. After this period candidate will be on a 4/10 hour shift (Sun- Wed or Wed - Sat) or a 3/4 shift (3 days one week/ 4 days the second week) these staff work 12 hours. With this new pay structure staff that work our swing shift (1pm - 12am (4/10hrs shifts)) or the 3/4 day shift get pay differential (10 - 15%)

***Must have proven Quality Assurance experience
**Must have lab setting and quality background as they will be supporting the lab staff and provide quality oversight

The Senior Associate QA role supports Amgen’s Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.

Duties include purposeful presence on the manufacturing floor, batch record review, SOP and MP revision approval, work order approval, and quality approval of deviations and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environm

Job Type: Contract

Salary: $15.00 - $32.45 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Thousand Oaks, CA: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 2 years (Required)
• Quality assurance: 3 years (Required)
• CAPA records: 3 years (Required)
• deviations: 3 years (Required)

Work Location: One location

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