Job Abstract

Lead Quality at the plant and supervise quality/lab staff to ensure that regulatory requirements for the manufacturing process are met, and consistent with relevant food and drug current Good Manufacturing Practices (cGMP) and the Quality Management system (QMS). Provide support and direction for process and product quality improvements and implementation of action plans. Work proactively with both internal and external customers to effectively resolve quality issues, initiate improvements, create preventive action, evaluate, and execute changes related to products, processes and procedures. Act as a Product Regulatory Affairs SME across HSM within the FDA cGMP and QMS space. Support all other HSM nutritional Quality Managers and systems as directed by manager.

• ?Ensure full cGMP compliance with ICH-Q7, 21CFR111, 21CFR117, QMS, and EH&S policies.
• Oversee daily Quality Control operations and supervise technicians.
• Direct product and raw material sampling, testing, and COA generation.
• Make shipment decisions based on quality tests and manage Change Control.
• Maintain Document Control, procedures, batch records, and quality records.
• Coordinate audits and corrective actions, including customer complaints.
• Conduct cGMP training and manage quality reviews and testing programs.
• Maintain HACCP/Food Safety Plan and oversee environmental testing.
• Ensure plant cleanliness and perform other assigned duties.
• Assure compliance with validation, process quality, and Cost of Poor Quality.
• Track and improve site quality metrics and manage Validation Master Plan.
• Assist in annual product review reports and update product specifications.
• Manage FDA and local health authority filings and maintain DMFs and Product Dossiers.
• Conduct internal audits and manage Change Control Program.

• Minimum 7-10 years in the food and/or drug regulated product industry; 4 years quality supervisor experience
• BS Degree in Chemistry, Food Science or other related field, advanced degree preferred
• Direct experience with working with the FDA during product applications and leading onsite inspections
• Ability to travel domestically 50%

Top Candidates will have:

• Granulation experience
• 3 years of experience engaging with external customers 

J.M. Huber Corporation complies with all local/state regulations requiring salary range transparency.

Any offered salary is determined based on relevant factors such as an applicant's skills, performance, job responsibilities, prior relevant experience, certain degrees and certifications and market considerations.