Quality Assurance Officer 1

Shift: 8AM-5PM or 8:30am-5:30pm (Flexible) Pay: $19.23-$23.08 (Depending on Experience)

Key Responsibilities:

• 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

Qualifications and Experience:

• High School Diploma +2 years of experience in GMP/FDA environment
• Associate's degree + 1 year of experience in GMP/FDA environment
• B.A. or B.S.
• Life Science degree preferred but not required
• Must be able to lift upwards of 30lbs