- Develop, document and maintain procedures as related but not limited to ISO 9000, HACCP, GMP, QC, QA, Chemical, Physical and Microbiological Assay procedures.
- Manage the audit process for ISO 9001, GMP/HACCP, Customer, and Regulatory, including recruitment and training of audit and plant personnel.
- Regulatory contact for industry group.
- Manage and direct Laboratory Supervisor to ensure the accuracy, proficiency, and quality of the analytical tests conducted and establish new technological processes.
- Ensure Management is informed regarding systems status, compliance and customer satisfaction via reports, memos, verbal reports, etc.
- Provide technical assistance to the Plant Management as required and related to problems of chemical, physical, microbiological, applications and regulatory nature.
- Review new equipment planning and process changes to ensure compliance with GMP, ISO 9000, HACCP, etc.
- Coordinate interaction between the sales group, production facility, and customers to ensure the capability of meeting customer requirements.
- Review certificates of analysis for compliance with analytical specifications and sign certificates of analysis to be forwarded to customer/review and signing of regulatory documents for delivery of required documentation.
- This Job Description shall include, but is not necessarily limited to, the above duties. May temporarily perform other duties assigned to maintain operations.
- Necessary procedures are in place to demonstrate compliance.
- Scheduled audits are performed covering all areas of the compliance systems minimally on annual basis. Key contact for Customer and Regulatory Audits. Filled out customer self-audits.
- Key contact person for GMIA regulatory matters.
- Scheduled audits cover the systems and cooperative testing with other gelatin facilities through statistical measurements demonstrate the proficiency of the assay results (GMIA and WW ring, AOAC Cross-Check program).
- This is done via reports both written and verbal, such as Audit Reports, Monthly Management Reports, Customer Complaint Reports, etc.
- Research updates of requested information.
- Compliance with regulations is measured through FDA, AIB, USDA and customer audits.
- This is measured by DIFOT, COA's affirming compliance and customer satisfaction.
- Reviewed through Customer Complaint reports, scheduled audits, monthly KPI's and DIFOT report. Documents timely and error-free.
- Quality training and plant personnel completed.
- This position requires 3-5 years of quality experience along with a Bachelors degree in chemistry or microbiology.
- Competent in ISO 9000, HACCP, & GMP.
- Strong leadership, communication, and computer skills recommended.
- Position reports to: General Manager of Operations
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Description
This position manages and maintains a Quality Control/ Assurance system and Food Safety Program which includes the continual development, monitoring, and management to ensure compliance with specification, customer requirements, and state/federal/international regulatory requirements. Our client is an international player who is recognized for the quality of products they bring to the marketplace.
Key Accountabilities: