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GMP Compliance Specialist

Location: Fargo, ND
Department: QC/Compliance
Days of Week: Monday-Friday
Hours: 8am-5pm (flexible)
Base Rate: DOE

Summary: The primary duty of this position is to collaborate with the Compliance Supervisor and department managers with the developing, writing, and implementation of Good Manufacturing Practice (GMP) policies, procedures and documents.

Essential Responsibilities:

  1. Support the development and implementation of the company’s GMP programs including written standard operation procedures.
  2. Facilitate the development and implementation of GMP required documentation including master batch records, validation protocols, sanitation records, and packaging records.
  3. Coordinate GMP training for all departments and location; may be asked to help with training sessions.
  4. Assist with verifying supplier compliance with GMPs through documentation review, auditing, verification of third-party certification results, etc; assure all vendor qualification documentation is on file and available for review by third-party auditors or regulatory authorities.
  5. Coordinate with the Compliance Supervisor and/or QA Supervisor to investigate potential GMP-related quality incidents, coordinate material reviews and properly document all activities.
  6. Participate in material review groups to resolve product non-conformances; collaborate with suppliers regarding improvement and track supplier progress; participate in periodic supplier performance feedback sessions.
  7. Participate in coordinating, preparing for, and hosting various third-party certification audits as well as regulatory inspections; assist with planning and executing required corrective actions. Be prepared to retrieve GMP-related documents quickly and easily.
  8. Submit periodic reports on assigned topics to appropriate personnel.
  9. Maintain a positive and professional working relationship with peers, management, and support resources, with a constant commitment to teamwork and exemplary customer service.
  10. Conducts self in the presence of customers and community so as to present a professional image of SHP.

Competencies Required:

  • Strong negotiation, collaboration and conflict resolution skills
  • Ability to prioritize and effectively multi-task
  • Excellent interpersonal skills
  • Strong oral and written communication skills
  • Strong knowledge of Microsoft Office products

Supervisory responsibilities: This position has no supervisory responsibilities.

Education and experience required. Bachelor of Science degree in Food Science, Biology, Chemisty or related field with a minimum of two years experience in quality assurance in a food, dietary supplement or pharmaceutical manufacturing environment. Or equivalent required in business, technical or legal coursework preferred with a minimum of two years experience in quality assurance in a food or dietary supplement industry. Or; an equivalent combination of education and experience sufficient to successfully perform the essential responsibilities and duties of the job as listed above

Equipment and software used:

  • PC
  • Multi-line telephone system
  • Fax machine
  • Copier/scanner
  • Calculator
  • Applicable company software

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable a qualified individual with disabilities to perform the essential functions of the position as required by state and federal law.

  • Ability to sit for extended periods of time- frequently
  • Ability to travel up to 25% of the time