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 standard operating procedures, and facilitates development and implementation of required documentation such as master batch records, validation protocols, sanitation records, and packaging records. The specialist coordinates GMP training across departments and locations and may assist with training sessions. Responsibilities also include verifying supplier GMP compliance, maintaining vendor qualification documentation, investigating potential GMP-related quality incidents, coordinating material reviews, and documenting activities. The role participates in resolving product non-conformances, working with suppliers on improvements, and tracking supplier progress. The specialist helps coordinate, prepare for, and host third-party certification audits and regulatory inspections, and assists with planning and completing corrective actions. Additional duties include submitting periodic reports, serving as the primary contact for assigned vendors, participating on 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 at least five years of experience in quality systems in a food, dietary supplement, or pharmaceutical manufacturing environment; alternatively, an equivalent combination of education and experience sufficient to perform the job duties.
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 the development and implementation of company GMP programs, including written standard operating procedures.
Facilitate development and implementation of GMP documentation, including master batch records, validation protocols, sanitation records, and packaging records.
Develop and coordinate GMP training for all departments and locations, and assist with training sessions as needed.
Verify supplier compliance with GMPs through documentation review, auditing, and verification of third-party certification results.
Ensure vendor qualification documentation is on file and available for third-party auditors or 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, track supplier progress, and participate in periodic supplier performance feedback sessions.
Coordinate, prepare for, and host third-party certification audits and regulatory inspections; assist with planning and executing corrective actions.
Retrieve GMP-related documents quickly and easily as needed.
Submit periodic reports on assigned topics to appropriate personnel.
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 demonstrate teamwork and exemplary customer service.
Present a professional image of Swanson Health Products when interacting with customers and the community.