Food and Safety Specialist

Mightyworks       |    Location:WI       |    Country:United States Of America

<p>This individual will monitor and support the Quality Management System at their site and other Food Safety and Quality Programs as needed to assure the compliance of products with all internal, customer, and regulatory requirements<br /> &nbsp;</p> <p><strong>Responsibilities</strong></p> <p>The essential functions of this position include, but are not limited to, the following:</p> <p>&bull; Provide leadership, coordination, insight and individual contribution in obtaining and maintaining Pharmaceutical API compliance</p> <p>&bull; Verification of batch records in compliance with various standards including: Dietary Supplements (21CFR111) and ICH Q7 API Active Pharmaceutical Ingredients</p> <p>&bull; Participate in customer, certification, and regulatory audits, and contributing to completing pre-audit questionnaires, and following up on corrective actions, as needed</p> <p>&bull; Contribute to effective management of Deviations, Corrective Actions, and Non-Conformances</p> <p>&bull; Contribute to monitoring and trending of process performance</p> <p>&bull; 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</p> <p>&bull; Organize quality and food safety training, internal audits, quality meetings, etc</p> <p>&bull; Communicate internally any information concerning GMPs, quality, and food safety</p> <p>&bull; Ensure adherence to Quality and Environmental Policies and Procedures</p> <p>&bull; Comply with all company policies, including maintaining a drug free work place</p> <p>&bull; Support an environment of continuous improvement within the assigned area and develop awareness for product and production quality</p> <p>&bull; Interact at various levels with other departments and regulatory agencies<br /> &nbsp;</p> <p><strong>Qualifications</strong></p> <p>&bull; Must have a Bachelor&rsquo;s degree in Microbiology, Biology, Food Science, or related field, and/or a minimum of 3 years&rsquo; experience in Quality Assurance or Quality Control, cGMPs, Food Safety, and Regulatory Compliance in the pharmaceutical or dietary supplements industry</p> <p>&bull; 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</p> <p>&bull; Experience working hands-on in a dietary supplement or similar manufacturing environment, including pre-operational inspections, internal audits, and compliance monitoring and trending</p> <p>&bull; Must possess effective communication, interpersonal, team-building skills at various levels with other departments</p> <p>&bull; Must possess strong organizational and time-management skills and the ability to work in-dependently</p> <p>&bull; Team-based problem-solving of manufacturing quality events, a plus</p> <p>&bull; Experience with regulatory and customer audits</p> <p>&bull; Experience with CAPA (Corrective &amp; Preventive Actions) systems, preferred</p> <p>&bull; Experience with training presentations relevant to regulatory compliance, GMPs, etc., preferred</p>