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Quality Assurance Senior Associate (JP8344)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Quality Assurance Senior Associate (JP8344)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 3.15.2021
Note: Onsite Essential
 
 
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:
  • This staff member will be assigned to provide quality support during either day or night shift schedule periods, as operation support is 24/7.
  • Biotech/pharma manufacturing, quality assurance, or quality control experience
  • The Senior Associate QA role supports the client’s Quality Assurance program, providing daily oversight of Drug Substance manufacturing facilities at the client’s 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.

    Top 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
 
Employee Value Proposition:
Dynamic team, lots of Science based environment exposure.
 
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 and in-person virtual interviews (webex)
 
 
 
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.
 
Regards,
 
3KC Talent Acquisition Team
 
 
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