Quality Systems Specialist

Swanson Health•Fargo, ND

About The Position

The Quality Systems Specialist collaborates with the Quality Systems Manager and department managers to develop, write, and implement Good Manufacturing Practice (GMP) policies, procedures, and documents. The role supports company GMP programs, including written standard operating procedures, and facilitates required documentation such as master batch records, validation protocols, sanitation records, and packaging records. The specialist develops and coordinates GMP training across departments and locations and may assist with training sessions. The position reviews supplier documentation, audits and verifies third-party certification results, and ensures vendor qualification records are available for audits and regulatory reviews. In partnership with the Quality Systems Manager, the specialist investigates potential GMP-related quality incidents, coordinates material reviews, documents activities, and participates in resolving product non-conformances and improving supplier performance. The role also helps coordinate, prepare for, and host third-party certification audits and regulatory inspections, and assists with planning and executing corrective actions. Additional duties include retrieving GMP documents, submitting periodic reports, serving as the first point of contact for assigned vendors, participating in the Sanitation Team, and maintaining professional, collaborative relationships with colleagues, management, support resources, customers, and the community.

Requirements

Bachelor of Science degree in Food Science, Biology, Chemistry, or a related field, with a minimum of five years of quality systems experience in a food, dietary supplement, or pharmaceutical manufacturing environment; alternatively, an equivalent combination of education and experience sufficient to perform the job responsibilities.
Strong negotiation, collaboration, and conflict-resolution skills.
Ability to prioritize and effectively multitask.
Excellent interpersonal skills.
Strong oral and written communication skills.

Responsibilities

Collaborate with the Quality Systems Manager and department managers to develop, write, and implement GMP policies, procedures, and documents.
Support development and implementation of company GMP programs, including written standard operating procedures.
Facilitate the development and implementation of GMP documentation, including master batch records, validation protocols, sanitation records, and packaging records.
Develop and coordinate GMP training for departments and locations, and assist with training sessions when requested.
Verify supplier GMP compliance through documentation review, auditing, and verification of third-party certification results.
Ensure vendor qualification documentation is on file and available to third-party auditors and regulatory authorities.
Investigate potential GMP-related quality incidents with the Quality Systems Manager, coordinate material reviews, and document activities.
Participate in material review groups to resolve product non-conformances.
Collaborate with suppliers on improvements and track supplier progress; participate in periodic supplier performance feedback sessions.
Help coordinate, prepare for, and host third-party certification audits and regulatory inspections, and assist with required corrective actions.
Retrieve GMP-related documents promptly and submit periodic reports on assigned topics.
Serve as the first point of contact for assigned vendors, provide timely information, and relay incoming information to the Quality Systems Manager and Quality Systems team.
Participate as an active member of the Sanitation Team.
Maintain positive and professional working relationships and represent Swanson Health Products professionally with customers and the community.