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MCS Senior Associate Quality Assurance
Thousand Oaks,, CADescription:
Note:
Job Details:
Preferred Qualifications:
Basic Qualifications:
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
PAY RATE : $37/Hr on W2.
"This posting is for Contingent Worker, not an FTE"
Note:
- DAY SHIFT- has potential to be some swing shift but would not be until 2025
Job Details:
- This position supports 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 & Engineering staff in the execution of their processes, procedures, and use of quality systems.
- Duties include purposeful presence on the shop floor, electronic batch record creation, 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 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.
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.
- 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.
- Solid understanding and application of aseptic behaviors and principles.
Basic Qualifications:
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
Top 3 Must Have Skill Sets:
- Experience working with Quality Systems / QA
- Ability to perform GMP operations
- BATCH RECORD EXPERIENCE (MANUFACTURING BACKGROUND EXPERIENCE)
- Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field (strongly preferred)
Day to Day Responsibilities:
- This role supports Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at 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 electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances 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 environment.
PAY RATE : $37/Hr on W2.
"This posting is for Contingent Worker, not an FTE"