QA/Food Safety Specialist
Our client is seeking a QA/Food Safety Specialist with Pharma or Dietary Supplement Manufacturing experience for their Madison, Wisconsin location. This Specialist will monitor and support the Quality Management System and other Food Safety and Quality programs as needed to assurance compliance of products produced. This position reports directly to the QA & Food Safety Manager and is responsible for the maintenance and verification of the Quality Management System of the site.
- 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 QA API Active Pharmaceutical Ingredients.
- Participate in customer, certification and regulatory audits, contribute to completing pre-audit questionnaires and following up on corrective actions as needed.
- Contribute to effective management of Deviations, Corrective Actions and Non-Conformances.
- Coordinate documentation control and contribute to ensuring quality procedures are up-to-date, complete and properly followed.
- Organize quality and food safety training, internal audits, and quality meetings.
- Communicate internally any information concerning GMP’s, quality and food safety.
- Ensure all Quality and Environmental policies and procedures are followed.
- Support continuous improvement.
- Comply with all company polices.
- Bachelors degree required in Microbiology, Biology, Food Science or related.
- Minimum 3 years experience in Quality Assurance or Quality Control, cGMP’s, Food Safety and Regulatory compliance in the pharmaceutical or dietary supplements industry is required.
- Must have experience with regulatory compliance of products regulated under FDA 21CFR111, FDA Q7A GMP’s 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.
- Experience with regulatory and customer audits.
- Experience with CAPA (Corrective & Preventative Actions) systems preferred.
- Experience with training relevant to regulatory compliance, GMP’s etc.