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Quality Assurance Senior Associate- Biotech/ Pharma experience (JP10112)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Quality Assurance Senior Associate- Biotech/ Pharma experience (JP10112)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 18 months with likely extensions
Job posting date: 4/21/2022
Rate: $28-32/Hr W2

Note: Onsite Essential, must be able to work swing, morning, evenings, night shift (24/7 Operation building). Once trained it will 4-day work week.

3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • 3 workers required for this role
  • Biotech/ Pharma experience required.
  • The Senior Associate QA role supports Amgen’s Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at Amgen 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 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.

Top Must have Skill Sets:
  • Biotech/ Pharma experience required.
  • Technical writing experience (i.e., deviation records, CAPA records, controlled documents)
  • Excellent verbal and written cross functional communication skills
  • Must have biotech/pharma manufacturing, quality assurance, or quality control experience.

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
Red Flags:
  • No biotech/pharma manufacturing, quality assurance, or quality control experience
  • Unable to work shifts including morning, evening, or potentially nights
  • Inability to effectively communicate across broad and diverse teams

Interview Process:
Phone Screens
In person virtual interviews

We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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