Quality Assurance Specialist

Candidate Select - Madison, WI

Quality Assurance Specialist

This individual will monitor, maintain, verify, and support the Quality Management System for a multi global pharmaceutical manufacturer. This individual must have a minimum of three years working experience utilizing regulatory compliance for ICH Q7, 21 CFR 111, and 21 CFR 211.

THIS POSITION IS A DIRECT HIRE, PERMANENT PLACEMENT ROLE

The Quality Assurance Specialist must perform these essential functions:

  • Verify batch records to ensure compliance with Dietary standards (21CFR111) and ICH Q7A,
  • Coordinate documentation control and contribute to ensuring quality procedures are up to date, complete and properly followed, and coordinate any modifications in compliance with certification standards and company guidelines.
  • Communicate internally any information concerning GMP’s, quality, and safety.
  • Contribute to the effective management of Deviations, Corrective Actions, and Non-Conformances.
  • Participate in customer, certification, and regulatory audits, and contributing to completing pre-audit questionnaires, and following up on corrective actions as needed.
  • Provide leadership, coordination, insight, and individual contribution in obtaining and maintaining Pharmaceutical API compliance.
  • Organize quality and food safety, training, internal audits quality meetings, etc.

Quality Assurance Specialist Qualifications:

  • Bachelor’s degree in Microbiology, Biology, Food Science, or related field.
  • Must have working experience in regulatory compliance and products under FDA 21CFR AND FDA Q7A Good Manufacturing Practices (cGMP).
  • Must have a minimum of three years’ experience in Quality Assurance or Quality Control. cGMP’s, and regulatory compliance in the pharmaceutical industry.
  • Experience working in a hands-on manufacturing environment, including pre-operational inspections, internal audits, and compliance monitoring, and trending.
  • Experience with training presentations relevant to regulatory compliance, GMP’s preferred.

OTHER:

  • Must be a US Citizen.
  • Full benefits package including medical, dental, vision, and life insurance. 401k participation, etc.
  • Relocation assistance will be considered for candidates that meet regulatory requirements.
  • Industry standards place the salary range for this role between $61,000 - $75,000.




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