Quality Assurance Technician - 2nd Shift

Bimeda•Le Sueur, MN

1d•Onsite

About The Position

This role will report to the Quality Assurance Supervisor with a dotted line to the Director or Quality Assurance. This role will audit and inspect the manufacturing process, product, reserves, documentation, and incoming components, such as labeling and packaging, to ensure compliance to cGMP and Bimeda Inc. quality standards.

Requirements

Practical experience with cGMPs within a regulated environment.
High School diploma or equivalent.
Excellent communication sills 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 top 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

Nice To Haves

Experience in an FDA, Canadian Health and/or EU regulated pharmaceutical manufacturing environment.
6 months of experience in pharma or food manufacturing or Quality Assurance
Bachelors Degree in a related science field
Experience and knowledge with Continuous Improvement programs.

Responsibilities

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