- Title: Quality Assurance Senior Associate
- Code: RCI-8907
- Location: Thousand Oaks California (CA) 91320
- Posted Date: 07/27/2021
- Duration: 18 Months
Talk to our Recruiter
- Name:Mittal Mandavia
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 245
*** Biotech/ Pharma experience required***
- The Senior Associate QA role supports Client’s Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Client’s site.
- 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 environment to ensure workplace safety.
- This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.
- Bachelors degree with 1 YOE OR Masters degree
Top 3 Must Have Skill Sets:
- Experience in biotech or pharmaceutical industry supporting manufacturing areas as plant quality assurance, manufacturing, quality control, or related staff.
- Technical writing experience (i.e. deviation records, CAPA records, controlled documents)
- Excellent verbal and written cross functional communication skills
Day to Day Responsibilities:
- Purposeful presence on the manufacturing floor (80% of working time spent on MFG floor in controlled, classified cell culture and protein purification areas).
- Batch record review
- SOP and MP revision approval
- work order approval
- quality approval of deviations and CAPAs
- Safety auditing and observational work
- GEMBA walks
Employee Value Proposition:
- The person in this role will have to make decisions related to product quality and other critical areas.