MQA specialist

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Highly Competitive + relocation
Mid-West, United States


Provide quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility. Has extensive knowledge of the manufacturing process and routinely evaluates and resolves process issues in cooperation with Production and support personnel to ensure product safety. Works closely with Production personnel to complete on-the-floor, in-process batch record review, resolve all batch related issues, and ensure proper good documentation practices. Recommend corrective actions or process improvements that will eliminate the potential for manufacturing deviations.

Key Responsibilities

  • Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes Ability to make independent decisions regarding quality related concerns or issues
  • Works closely with MQA Supervision, as needed
  • Demonstrate a proficient knowledge of the manufacturing process and site procedures
  • Addresses daily quality concerns and questions related to operating and environmental issues. Implements and follows up on corrective actions
  • Clearly communicate complex issues to Management personnel
  • Evaluates the manufacturing areas for recommended improvements that will eliminate the potential for deviations
  • Provide backup support to the Environmental Monitor group as needed and as approved by management
  • Manage metrics on a regular basis, as applicable
  • Work closely with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling
  • Completes gown qualification and maintains status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices
  • Identify deviations and ensure the deviations are initiated by the appropriate personnel
  • Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities
  • Assists in analysis of inspection rejects; assists in investigation of causes and implementation of corrective actions
  • Performs AQL checks on product when necessary and maintain AQL qualification status
  • Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Incumbent must be able to provide real-time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation
  • Inspect the physical conditions of the aseptic manufacturing area on a routine basis
  • Provide regular updates about aseptic behaviors and aseptic gowning performance to the production department, support groups, and site leadership
  • Complete monthly inspections of the physical conditions of the manufacturing support areas and report issues to MQA Supervision
  • Provide good aseptic technique and gown re-training to individuals, as required per the RPN program

Candidate Requirements

  • Bachelor of Science degree in Life or Physical Sciences
  • Proven background in the pharmaceutical sector Knowledge of a production facility and/or inspection processes are a must
  • Excellent cGMP knowledge
  • Quality or Pharmaceutical certifications a plus
  • Sterile manufacturing and aseptic filling experience
For more info contact: David Potter
Email Address:
Contact Number: +44 (0) 753 973 7331
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