Supervisor - Quality Assurance - Compliance
2 months ago
Manages internal audit program and Quality and Food Safety change management process as it relates to new products, equipment, or processes.
Oversees the site's Food Safety Plan and HACCP plans
Manages the pre-requisite programs for the HACCP and Food Safety Plans (pest control, temp chart recorders, internal facility audits)
Monitors process indicators and assures central data collection related to quality, compliance, certifications, and management system.
Responsible for ensuring facility's SOPs are aligned with 21 CFR Part 110, 111 and 117 regulations as it pertains to quality systems, pest control, and audits.
Oversees recalls with the FDA, including but not limited to gathering customer information, performing mass balance, changing Oracle status, communicating with FDA, etc.
Oversees the company's FSVP program to ensure compliance to FSMA regulations.
Leads the company's annual compliance requirements such as Mock Recall Program, Food Safety Meetings, Food Defense Challenge, etc.
Documents investigations related to nonconformance related to chart recorders.
Serves as facility liaison for external pest control provider, contacts area management for the corrective actions and provides reports to Compliance Management.
Assists with the development, implementation, review and maintenance of the SQF system, including food safety fundamentals and food safety plan.Takes appropriate action to ensure the integrity of the SQF system and communicates to all relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF system.
Manages the Food Defense and Food Fraud programs for the facility.
Supports a culture of safe production and operations; Actively participates in the safety program by: engaging in training activities to learn what constitutes a safety hazard; Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Bachelor's degree (B.or equivalent from four-year college or technical school in food science, chemistry, physics or related field, and a minimum of seven years quality-related experience or equivalent combination of education and experience.
Strong knowledge of dietary supplements (or similar field), including familiarity with 21 CFR 111 and 117, FSMA and GFSI (SQF).
Strong computer skills is required, including intermediate level of proficiency with Word, Excel and PowerPoint.
Dietary supplement or pharmaceutical industry experience preferred.
General understanding of the concepts involved in quality control/assurance and food safety and the ability to relate these concepts to any problems that arise.
Intermediate experience with electronic documentation management system software is preferred.
Proficient in Microsoft Office (Word, Excel, PowerPoint).
Ability to read and interpret documents such as interpret general technical procedures, legal and/or governmental regulations.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to work at a desk and enter information into a computer. The employee frequently is required to use a computer and keyboard and to communicate in person and by telephone. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
~ As required, works in a loud area that requires hearing protection and other protective equipment to be worn.
~ and chemicals such as alcohol, that may require respiratory protection.
~ May be exposed to potentially hazardous chemicals and biological materials.
~ Intermittently exposed to all of the FDA designated major food allergens (Milk, Eggs, Fish, Crustacean shellfish (e.g. crab, lobster, shrimp), Tree nuts (e.g., 15-20% travel, including travel by plane, may be required.
~ Must be able to work a flexible schedule, including off shifts and weekends.
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