Quality Assurance Officer 3

Employer: TechLab, Inc.
Job Location: Blacksburg, Virginia
Category: Quality Assurance
Employment Type: Full Time
Last Updated: 5/31/2024
Closing Date: 7/5/2024
TechLab, Inc.TechLab, Inc.
TECHLAB®, Inc. develops, manufactures, and distributes rapid non-invasive intestinal diagnostics in the areas of intestinal inflammation, antibiotic associated diarrhea and parasitology.
http://www.techlab.com
Job Description Quality Assurance Officer 3
TechLab, Inc. develops, manufactures, and distributes medical diagnostic tests. This company places emphasis on science and collaboration with Universities. We are looking to add a Quality Assurance Officer 2 to our team.
An employee in this position can expect to perform the following duties:
  • Issuing and Reviewing MBRs in support of Production schedule
  • Issuing/confirming Lot Expiration Dates of Raw Materials, Components and Finished Products
  • Create, review and apply QA Release Labels
  • Review QC results detailed per SOPs, RMSs and PRSs
  • Ensure approved documents (MBRs, SOPs, TLFs) are issued and controlled
  • Ensure Controlled Records are controlled and easily retrievable
  • Initiating and verifying proposed changes as Document Circulation Requests (DCRs) and Sage Change Request (SCRs)
  • Perform Visual Inspection of Raw Materials, Foil/Label Inspection and AQL testing of packed kits
  • Perform Lot Release/Acceptance of Raw Materials, Components and Finished Products
  • Ensure Non-Conformities and CAPA are identified, investigated and controlled
  • Determining Quality Impact of Non-Conformities and Effectiveness of CAPAs
  • Deliver New Hire Training
  • Perform impact and risk assessments
  • Complete projects as assigned by QA Manager or QA Supervisor.
  • Approve Lot Expiration Dates
  • Disposition Raw Materials, Components and Finished Products
  • Approve Manufacturing/Packaging MBRs
  • Approve Quality System documentation (MBRs, SOPs, TLFs)
  • Approvals of DCRs, SCRs and Non-Conformity Reports
  • Approve risk assessments
 
Tools and Equipment Used
Ensur document processing system
Microsoft Office Suite
 
Job Context
TechLab maintains a climate-controlled environment for the job of Quality Assurance Officer 3. An employee in this position must be able to lift upwards of 30lbs. A typical workweek is Monday through Friday 8:00 to 4:30 or 8:30 to 5:00. Overtime is occasionally necessary with or without advance notice.
 
Minimum Qualifications
High School Diploma or Associate’s Degree + 4 years of experience in GMP/FDA environment
B.A. or B.S.+ 3 years of experience in GMP/FDA environment
Master’s Degree +2 years experience in GMP/FDA environment
Life Science degree preferred but not required


Interested candidates should send a resume to careers@techlab.com, Blacksburg, Virginia 24060. EOE.
 
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