Specialist QA – Biologics (JP4903)

Location: Woburn, MA
Date Posted: 10-24-2018
Job Title: Specialist QA – Biologics (JP4903)
Job Site: Woburn, MA  01801
Type: Contract
Duration: 6 months with likely extension
Business Unit: ABV QA Plant Quality Assurance
 
3Key Consulting Inc. is looking for role for a QA Specialist with experience in Biologics manufacturing, for a global, CA-based, bio-pharmaceutical company.
 
Job Details:
Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured Amgen.


Primary responsibilities of this position include:
  • Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
  • Ensures that facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations
  • Responsible for ensuring raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements
  • Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures
  • Ensures that deviations from established procedures are immediately triaged, investigated and documented per procedures
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
  • Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks
  • Alerts senior management of significant quality, compliance, supply and safety risks
  • Perform AQL for Visual Inspection (must have successful passing results visual test before)
  • Release of gases, cell banks and labels
  • Oversight the Aseptic Processing filling and provide advice and guidance during the process
     
Top Must Have Skill Sets:
  • 5+ years of manufacturing experience in Biologics.
  • Targeting validation exp., non-conformance, CAPA, Change Control and Tackwise experience
  • Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk, pass gowning certification, pass visual test to perform AQL.
  • Flexible to work different shift and managing multiple priorities at the same time.
     
This person will primarily be working 1st shift. Must be willing to work 2nd shift depending on operation needs.
 
Employee Value Proposition:
This team is always striving for excellence. The best Bio-technical company in the world. This person would gain product life-cycle experience with the THAW process up to final dosage (formulation to filling exp.).
 
Red Flags:  
  • No QA experience
  • No technical writing skills
  • Must be able to articulate their thoughts well.
 
Interview Process:  
Phone interview then in person OR straight to in person interview.
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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