Specialist Quality Assurance Drug Manufacturing (JP4462)

Location: Woburn, MA
Date Posted: 07-03-2018
Job Title:  Specialist Quality Assurance Drug Manufacturing (JP4462)
Location: Woburn, MA 01801
Employment Type:  Contract
Business Unit:  ABV QA Plant Quality Assurance
Duration: 6+ months (likely extensions)
 
3Key Consulting Inc. is recruiting for a Specialist Quality Assurance with 3 - 5 years’ experience in QA validation and compliance in drug manufacturing for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
Candidate will have previous experience in QA, validation, or compliance areas.  This position will be 75% on the floor / ~25% at the desk (document review), 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 but must be willing to work 2nd shift depending on operational needs. 
 
  • Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured Amgen.
  • 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:
  • Previous experience in QA, Validation, or compliance areas, 75% on the floor / ~25% at the desk (doc review).
  • Must pass gowning certification and pass visual test to perform AQL.
  • Flexibility to work different shift and managing multiple priorities at the same time.
 
Day to Day Responsibilities
  • Responsible for all quality oversight functions related large molecule Bulk Drug Substances (BDS), Drug Products (DP), and Finished Products (FP) manufactured Amgen.
  • 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.
 
Why This Position Is Open:
Need additional headcount to absorb redistribution of workload.
 
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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