The purpose of this position is to manage the site Quality Assurance department, ensure regulatory compliance at the facility, and provide technical support.
The essential functions of the position include, but are not limited to:
- Ensure facility compliance with FSMA, Good Manufacturing Practices and Dietary Supplement Current Good Manufacturing Practices (CGMPS) and any other applicable local, state, federal and international regulatory requirements.
- Ensure adherence to an effective FSMA food safety plan, HACCP and required food safety programs such that manufacturing processes limit microbial risks and potential for cross-contamination.
- Implement quality assurance programs that effectively monitor product manufacturing in a way that results in company compliance with regulatory, FSMA, CGMPs, HACCP, food safety plans and GFSI standards for 3rd party audits.
- Participate and contribute to continuous improvement of departmental SOPs.
- Oversee or manage raw material, in-process, and finished product testing.
- Conduct Quality Assurance review and disposition of raw materials and finished products.
- Issue or oversee the issuance of Certificates of Analysis for finished products.
- Track, monitor, document, and review quality investigations, out of specification results, deviations, and complaints using quality tools such as root cause analysis.
- Resolve quality processing issues through the use of and participation in cross functional teams. This will require trending and review of associated quality investigations, out of specification results, deviations, and complaints.
- Lead the facility Quality Assurance team to foster continuous quality improvement.
- Conduct or assist with manufacturing site quality system, FSMA, food safety, CGMPs, sanitation and other required training.
- Develop and support supplier, customer, and regulatory agency relationships. This includes fulfilling customer sample requests and completing required questionnaires.
- Monitor the activities of approved warehouses, suppliers, contract laboratories, and contract manufacturers as needed.
- Conduct and/or assist in contractor, supplier, and internal facility audits.
- Conduct and/or assist with federal (FDA), state, local, international, and third party audits.
- Implement and monitor the Pest Control and Environmental Monitoring Programs at the manufacturing site.
- Implement corrective and preventative actions base on regulatory inspections, third party audits, internal audits, customer complaints and contract manufacturing issues.
- Review and approve facility procedures, protocols and other technical documents (raw material specifications, in-process specifications, finished product specifications, master manufacturing records and batch production records).
- Maintain SDS, allergen, process flow and special requirement documents for all incoming raw materials and finished products.
- Assist with disposition decisions for products impacted by quality, food safety, or sanitation issues.
- Provide input on product recall decisions and participate with any recalls.
- Implement corporate compliance programs and initiatives.
- Assist Research and Development with new suppliers, new products, process improvements, and additional projects at the facility or during start-up preparations.
- Manage site Quality Assurance budget.
- Other duties as assigned by Corporate Q.A. Manager.
The minimum education and background experience needed for this position are:
- BA/BS degree -Technical or science related field such as biology, microbiology, chemistry or food science.
- 5+ years’ experience in the food, dietary supplement or pharmaceutical industry.
- 3 – 5 years Quality Assurance management experience.
- Experience using and implementing new laboratory analytical testing equipment.
- Competency with Food Good Manufacturing Practices, Dietary Supplement Current Good Manufacturing Practices, and associated regulatory requirements.
- Demonstration of successful implementation of food safety, HACCP, and quality programs.
- Experience in writing Quality Assurance related specifications, test methods, standard operating procedures, protocols, and manuals.
Salary : $80,000 – $95,000