14327709
Located in Blacksburg, VA
Pay: $44,000 - $48,000
Job Full Description
Job Summary
The Quality Assurance Officer 1 is responsible for ensuring that all products meet the requirements of the quality system. This can include reviewing and tracking product as well as reviewing documentation to ensure it complies with regulatory standards.
Work Activities
- · 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 proposed changes as Document Circulation Requests and Sage Change Requests
- · Perform Visual Inspection of Raw Materials, Foil/Label Inspection and AQL testing
- · Ensure Non-Conformities and CAPA are identified, investigated and controlled
- · Initiate Non-Conformity documentation and determine the Quality Impact.
- · Deliver New Hire Training
- · Approve Lot Expiration Dates
- · Disposition Pre-Raw/Raw Materials, Components, and Finished Goods
- · Approve Manufacturing/Packaging MBRs
- · Complete projects as assigned by QA Manager or QA Supervisor
Tools and Equipment Used
- Ensur document processing system
- Microsoft Office Suite
An employee in this position must be able to lift upwards of 30lbs. A typical workday 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 +2 years of experience in GMP/FDA environment
- Associates Degree + 1 year of experience in GMP/FDA environment
- B.A. or B.S.
- Life Science degree preferred but not required
New River Valley, VA
2542
3225 North Franklin Street
Suite 10
Christiansburg, VA 24073
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