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MCS Senior Associate Quality Assurance
Advanced Bio-Logic Solutions Corp Thousand Oaks, , CA 91360
Posted 2 months ago
Description:Note:
- Must be flexible as it is possible worker will start on any shift. Rotate every 6 months.
- DAY 7 AM - 8 PM
- SWING 1 PM to Midnight
- NIGHT SHIFT 7 PM - 8 AM
- Will change on the business they are supporting
- Rotate every 6 months
- This position supports 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.
- 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.
- 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
- Experience working with Quality Systems / QA
- BATCH RECORD EXPERIENCE
- Plant Quality Assurance providing quality oversight to manufacturing
- Looking for someone who can work cross functionally amongst many different teams and be comfortable with shifting priorities as the business needs change.
- 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.
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