Quality Assurance Specialist - Pharmaceutical & Food/ FSVP

Purpose

Benuvia Operations is seeking an experienced Quality Assurance Specialist to support Quality Systems across pharmaceutical and food-regulated operations. A primary initial responsibility will be to support the development, implementation, and maintenance of the Company's Foreign Supplier Verification Program (FSVP) for the importation of food ingredients into the United States.

The successful candidate will have demonstrated experience in the food industry, including practical knowledge of FDA food safety requirements, supplier qualification, food hazard analysis, and FSVP requirements under 21 CFR Part 1, Subpart L. This position will also support the pharmaceutical Quality Management System, including deviations, CAPA, change control, supplier quality, audits, training, document control, risk assessments, and other Quality Assurance activities.

This is a hands-on Quality position requiring an individual who can assist in building and implementing Quality Systems, not simply administer established programs.

Duties and Responsibilities

Food Quality and FSVP

• Support the development, implementation, and ongoing maintenance of Foreign Supplier Verification Program (FSVP).
• Assist with assessment of applicable FDA and FSMA requirements for imported food ingredients.
• Develop and revise SOPs, forms, templates, checklists, and other controlled documents required to support the FSVP.
• Perform or support documented food hazard analyses for imported food ingredients.
• Evaluate known or reasonably foreseeable biological, chemical, and physical hazards associated with imported food ingredients.
• Support evaluation of hazards including microbiological contamination, heavy metals, mycotoxins, pesticide residues, allergens/cross-contact, foreign material, and other hazards associated with the food, manufacturing process, country of origin, and supply chain.
• Develop and maintain risk-based foreign supplier qualification, approval, monitoring, and reevaluation processes.
• Review supplier questionnaires, regulatory history, food safety plans, certifications, audit reports, Certificates of Analysis, laboratory testing, corrective actions, and other supplier documentation.
• Assist in determining appropriate supplier verification activities based on identified hazards and supplier performance.
• Support qualification and ongoing monitoring of foreign food suppliers.
• Establish and maintain FSVP records in an inspection-ready state.
• Support supplier corrective actions and investigation of food safety or supplier-related issues.
• Support periodic and event-driven reevaluation of foreign suppliers and FSVPs.
• Assist with development and implementation of appropriate incoming material testing and verification strategies.
• Support training of personnel performing FSVP activities.
• Support FDA FSVP inspections and records requests.
• Monitor applicable FDA food safety requirements and guidance for changes that may affect FSVP.

Pharmaceutical Quality Assurance

• Support the pharmaceutical Quality Management System and applicable cGMP requirements.
• Initiate, review, investigate, and/or support deviations and investigations, Corrective and Preventive Actions (CAPA), change controls, quality risk assessments, supplier qualifications, supplier corrective actions, document revisions, training activities, and quality metrics and trending.
• Review Quality events for completeness, appropriate investigation, root cause, impact assessment, and corrective actions.
• Support qualification and ongoing monitoring of pharmaceutical raw material, component, contract laboratory, and service suppliers.
• Draft and revise SOPs, specifications, forms, Quality Agreements, risk assessments, and other controlled Quality documents.
• Support internal audits, supplier audits, customer audits, and regulatory inspections.
• Support inspection-readiness activities.
• Assist with Quality System improvement initiatives and implementation of new Quality processes.
• Provide Quality support to Operations, Quality Control, Supply Chain, Regulatory Affairs, and other functional areas as required.

Quality System Development and Integration

• Evaluate existing pharmaceutical Quality Systems to determine where established processes may appropriately support food/FSVP operations.
• Assist in integrating food-related activities into existing document control, training, CAPA, change control, supplier management, and audit systems where appropriate.
• Develop food-specific procedures and controls where existing pharmaceutical procedures do not adequately address applicable food regulatory requirements.
• Ensure appropriate distinction between pharmaceutical cGMP requirements and food/FSVP regulatory requirements.
• Identify opportunities to simplify and improve Quality processes while maintaining regulatory compliance.
• Participate in continuous improvement of the overall Quality Management System.

Working Conditions / Physical Requirements

• Ability to stand for up to 8 hours per day.
• Frequent sitting, standing, walking, reading written documents and use of computer monitor screen, talking, writing, listening.
• Occasional lifting and/or moving up to 25 pounds.