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Senior Associate Quality Assurance
2 months ago
HERE’S THE JOB DESCRIPTION:
Title: MCS Senior Associate Quality Assurance #12932 (2 openings)
Pay Rate: $33.00-36.00/hr
Location: Thousand Oaks, CA 91320
Length: 3 year contract
Shift: Various shifts available - Must be flexible to support day/swing/night shifts
Candidates must be flexible with the hours they can work. Selected candidates will be placed on one of the following shift schedules and will rotate every 6 months:
- DAY SHIFT: 7 AM - 8 PM or 6AM - 5PM
- SWING SHIFT: 1 PM to Midnight
- NIGHT SHIFT: 7 PM - 8 AM
Job Details:
- This position supports the Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas.
- Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
- Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations and CAPA records.
- 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 for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
Day-to-Day Responsibilities:
- Electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs.
- Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
- 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 environment
Preferred Qualifications:
- 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.
- Also, ability to make Quality based decisions in order to ensure compliance.
- Experience managing projects through to completion & meeting timelines.
- Evaluating 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.
Top Must Have Skills:
- Experience working with Quality Systems / QA
- BATCH RECORD EXPERIENCE
- Plant Quality Assurance providing quality oversight to manufacturing.