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  • Job reference: RMS0227184

QA/Food Safety Specialist (Pharma or Dietary)

  • Sector: Engineering
  • Location: Madison, Wisconsin
  • Job type: Permanent
  • Date posted: 10/09/2020
  • Duration: direct hire
This vacancy has now been filled.

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The Role:
As part of our client's Nutrition and Biosciences division, this individual will monitor and support the Quality Management System at their Madison site and other Food Safety and Quality Programs as needed to assure the compliance of products produced by or for client with all internal, customer, and regulatory requirements. This position reports directly to the QA & Food Safety Manager for the Madison site and is directly responsible for the maintenance and verification of Quality Management Systems at the Madison site.


The essential functions of this position include, but are not limited to, the following:

* Provide leadership, coordination, insight and individual contribution in obtaining and maintaining Pharmaceutical API compliance
* Verification of batch records in compliance with various standards including: Dietary Supplements (21CFR111) and ICH Q7 API Active Pharmaceutical Ingredients.
* Participate in customer, certification, and regulatory audits, and contributing to completing pre-audit questionnaires, and following up on corrective actions, as needed.
* Contribute to effective management of Deviations, Corrective Actions, and Non-Conformances
* Contribute to monitoring and trending of process performance
* 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.
* Organize quality and food safety training, internal audits, quality meetings, etc
* Communicate internally any information concerning GMPs, quality, and food safety.
* Ensure adherence to client Quality and Environmental Policies and Procedures.
* Comply with all company policies, including maintaining a drug free work place.
* Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality.
* Interact at various levels with other departments and regulatory agencies.

* Must have a Bachelor's degree in Microbiology, Biology, Food Science, or related field, and/or a minimum of 3 years' experience in Quality Assurance or Quality Control, cGMPs, Food Safety, and Regulatory Compliance in the pharmaceutical or dietary supplements industry.
* Must have experience with regulatory compliance of products regulated under FDA 21CFR111, FDA Q7A GMPs for API, or other relevant compliance experience with manufacturing of pharmaceuticals, dietary supplements, medical devices, or excipients.
* Experience working hands-on in a dietary supplement or similar manufacturing environment, including pre-operational inspections, internal audits, and compliance monitoring and trending.
* Must possess effective communication, interpersonal, team-building skills at various levels with other departments.
* Must possess strong organizational and time-management skills and the ability to work in-dependently.
* Team-based problem-solving of manufacturing quality events, a plus.
* Experience with regulatory and customer audits.
* Experience with CAPA (Corrective & Preventative Actions) systems, preferred.
* Experience with training presentations relevant to regulatory compliance, GMPs, etc., preferred.

About Fircroft:
Fircroft has been placing people in specialist technical industries for over 50 years, focusing on mid to senior level engineers for contract and permanent roles worldwide. By applying for this job you give consent for Fircroft to contact you, via email & telephone, to discuss your application along with future positions and Fircroft's services.

Fircroft is registered as a Data Controller with the Information Commissioner as required under the General Data Protection Regulation 2016/679. Fircroft will only process your personal data for the specific purposes of managing your application.

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