Quality Assurance Technician - 2nd Shift

Position Overview

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.

Role 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.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance.  Respects others.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

ATTENDANCE/PUNCTUALITY – Meeting expectations requires that the employee regularly reports for work on time, prepared to start his/her assigned duties at the appointed time.  Report-for-duty time is defined as readiness to perform the first assigned task at the scheduled start of a shift and employee does not leave assigned post early, works through the end of work hours.    Employee leaves and returns from scheduled breaks and lunch at designated times.

Other Requirements

Essential: 

• 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 writte