Technician Select Category and delete this line
Radford, VA
This is a Careers Position
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.