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.
Job Type: Full-time
Pay: From $57,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
Work setting:
Education:
- High school or equivalent (Required)
Experience:
- GMP/FDA environment: 2 years (Required)
Ability to Commute:
- Radford, VA 24141 (Required)
Ability to Relocate:
- Radford, VA 24141: Relocate before starting work (Required)
Work Location: In person