Quality Assurance Specialist - Pharmaceutical & Food/ FSVP

Benuvia Operations is seeking an experienced Quality Assurance Specialist to support Quality Systems across pharmaceutical and food-regulated operations. A primary initial responsibility of this position 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. In addition to food and FSVP responsibilities, this position will 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. REPORTS TO Reports to the Vice President of Quality and will have interactions with members of other departments including Quality Control, Manufacturing, Quality Assurance, Research & Development, Facilities, and outside customers. 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, as applicable, 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 Document revisions Training activities 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. REQUIRED QUALIFICATIONS (Education, Experience, Knowledge, and Skills) Bachelor's degree in Food Science, Chemistry, Microbiology, Biology, Pharmaceutical Sciences, Quality, or a related scientific discipline, or equivalent relevant experience. Minimum of 5 years of Quality Assurance, Food Safety, Supplier Quality, or Quality Systems experience in an FDA-regulated industry . Demonstrated Quality Assurance experience within the food industry . Practical knowledge of FDA Foreign Supplier Verification Program requirements under 21 CFR Part 1, Subpart L . Experience supporting the development, implementation, or maintenance of an FSVP. Experience performing or reviewing food hazard analyses. Experience with supplier qualification, supplier monitoring, and supplier verification activities. Working knowledge of FSMA and applicable FDA food safety requirements. Experience developing and revising SOPs, forms, risk assessments, and other Quality System documentation. Experience with Quality Systems such as CAPA, deviations/investigations, change control, document control, training, supplier quality, and audits. Strong technical writing, organizational, problem-solving, and communication skills. Ability to work independently and manage multiple Quality projects and priorities. Preferred Qualifications Experience working within a pharmaceutical cGMP Quality System. Working knowledge of 21 CFR Parts 210 and 211 . FSPCA Preventive Controls for Human Food (PCQI) training. Experience with agricultural commodities, botanical materials, or imported food ingredients. Experience with GFSI-recognized food safety certification programs such as SQF, BRCGS, or FSSC 22000. Experience supporting FDA food or FSVP inspections. Experience with pharmaceutical manufacturing, API manufacturing, or a pharmaceutical CDMO. Experience participating in internal, supplier, customer, or regulatory audits. Experience with electronic Quality Management Systems. 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. LOCATION This position requires to be onsite in Round Rock, Texas. Rock Round is located 15 miles north of Austin. Applicants must be legally authorized to work in the U.S. Visa sponsorship is not available at this time. #J-18808-Ljbffr Benuvia