About The Position

In this role, you will provide shop floor quality support to the manufacturing group. MQA’s will provide review records, support maintaining prescribed housekeeping standards, and liaise with manufacturing personnel to ensure compliant and timely cGMP manufacturing.

Requirements

  • Five + years’ manufacturing experience in a cGMP environment.
  • Candidates must be legally authorized to work in the United States.

Nice To Haves

  • Practical Exposure to quality systems (sampling, testing, reviewing, approving).
  • Proficiency in Microsoft Excel and Word.
  • Excellent organization and time management skills.
  • Strong communication skills for issues, troubleshooting actions, and resolution options.
  • Strong grammar and proofreading/editing skills.
  • Ability to stand for extended periods of time, squat, grasp, lift containers in excess of 20 lbs.
  • Ability to wear PPE as required by the work area.
  • Demonstrated ability to perform basic math functions.

Responsibilities

  • Partner with shift production supervisor to identify and resolve quality issues in support of ongoing, right-first-time manufacturing.
  • Investigate issues and collect supporting information and documentation to initiate deviations.
  • Document events accurately and timely.
  • Act as a liaison between Quality and Manufacturing to ensure compliance with cGMP standards.
  • Perform quality monitoring, including packaging startup checks and release, ongoing quality inspections, and other quality monitoring of the manufacturing area.
  • Conduct batch record and other document reviews at defined intervals and work with appropriate personnel to correct errors impacting batch release.
  • Pull raw material samples and tag RM’s and components for release; perform general troubleshooting of receipt issues.
  • Collaborate with shift supervisor and manufacturing personnel to maintain an exceptional level of housekeeping throughout the facility.
  • Pull labels for process orders; perform label accountability calculations and investigate as needed.
  • Perform raw material verifications for compounding records.
  • Support continuous improvement efforts.
  • Perform other tasks as directed by supervisor or to support the needs of the business.
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