Quality Assurance/Manufacturing Batch Record Reviewer
4 weeks ago
Job Title: MCS Senior Associate Quality Assurance
Location: Thousand Oaks, CA
Shift: Day & Swing shift
Terms: Contract W2
Description:
Fully onsite at the Thousand Oaks facility not remote
6 months WITH extension as long as things are going well
M- F 7am-4pm / 10am-7pm swing shift. Must be able to commit to swing shift - 10% differential for swing shift. Must be flexible Shifts will shift based on production schedule
Ideal candidate: They will be working on the manufacturing floor.
Detail Oriented, Team player and Quality Experience.
The Sr. Associate Quality Assurance position supports’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.
Duties include but are not limited to:
Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments,
Electronic batch record review,
SOP revision approval,
Maximo System - Work order, job plan approvals,
Quality support and approval of minor deviations and CAPA records.
MES revisions and approvals
Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
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