Job Details

  • Title: Quality Assurance Senior Associate
  • Code: RCI-8907
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 07/27/2021
  • Duration: 18 Months
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  Job Description

Description:

***Onsite***

*** 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.

Basic Qualifications:

  • 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.