Quality Assurance Technician - 2nd Shift

Quality Assurance Technician - 2nd Shift

This role will report to the Quality Assurance Supervisor with a dotted line to the Director or Quality Assurance. The role audits and inspects the manufacturing process, product, reserves, documentation, and incoming components—including labeling, packaging, and printed materials—to ensure compliance with cGMP and Bimeda Inc. quality standards.

• Conduct incoming inspection of printed roll-stock, labels, inserts, and cartons using statistical sampling plans to determine the acceptability of printed labeling.
• Interact with label vendors to resolve issues.
• Conduct incoming inspection of packaging components.
• Perform initial and final inspections of the packaging lines to ensure compliance with company Standard Operating Procedures.
• Review equipment cleaning and usage logs.
• Write, review, and revise Standard Operating Procedures and related forms for job-related activities.
• Support the Continuous Improvement program throughout the company.
• Review batch documentation for cGMP compliance. Work with production personnel to resolve discrepancies. Perform QA release of finished product, including counting and tagging outgoing pallets of finished products. Establish files for all batch documentation and enter test results in the product database for later trending during the annual product review.
• Conduct the annual inspection of retained samples and investigate any discrepancies.
• Interface with FDA compliance officers during facility inspections.
• Perform final reconciliation of raw materials and finished packaged products to ensure all materials are accounted for within established limits, initiating investigations to the appropriate department if discrepancies are found.
• Prepare raw materials and finished product samples for submission to the Quality Control laboratory, enter appropriate information in logbooks, monitor completion of testing and receipt of necessary documentation to facilitate Finished Product and Raw Material releases. Review completed analysis for conformance to specifications and release acceptable lots.
• Keep Management informed of discrepancies, deviations, investigations, and unusual trends as they occur.

• Practical experience with cGMPs within a regulated environment.
• High School diploma or equivalent.
• Excellent communication skills for liaising and communicating with internal departments.
• Strong problem identification and problem resolution skills.
• High level of proficiency with Microsoft Office.
• Good written and verbal communication skills.
• Physical ability to transport and maneuver 100lb roll stock rolls.
• Ability to bend, squat, and lift 25lbs.
• Highly motivated and self-directed, capable of multi-tasking and able to work with minimal supervision.
• Ability to work independently.
• Extremely detail-oriented and analytical thinker.
• Strong work ethic and positive team attitude.
• Experience in an FDA, Canadian Health, and/or EU regulated pharmaceutical manufacturing environment.
• Six months of experience in pharma or food manufacturing or Quality Assurance.
• Bachelor’s Degree in a related science field.
• Experience and knowledge with Continuous Improvement programs.

• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.