cGMP Specialist Job Description Sample Template

JOB TITLE:

  • cGMP Specialist

DUTIES and RESPONSIBILITIES:

  • Completes all cGMP logs and documentation as well as batch records for each infused edibles batch produced. These logs and records include but are not limited to CAPA, Approved Suppliers, Monthly GMP inspection forms, Preventative Maintenance Schedules, Maintenance Logs, Equipment Calibration Schedules, Master Cleaning, and Sanitation Schedule, Employee Training Records, SDS’s, and HACCP Plans.
  • Provides verification and validation of facility operations and equipment.
  • Possesses advanced problem-solving, troubleshooting, and consultation abilities.
  • Actively collaborates with Director, Floor Manager, and Inventory Lead to resolve any and all discrepancies in a timely and compliant fashion.
  • Serves as a resource to facility management in identifying and assessing the appropriate complement of resources and support needed to successfully implement and execute projects.
  • Ensures all materials received are stored in the proper location.
  • Maintains confidentiality in any and all aspects of the organization.
  • Performs duties in a cleanroom environment when needed and while fully gowned (e.g., properly applied face mask, scrubs, gloves, etc.), following cGMP guidelines and using aseptic techniques. Works with senior staff to ensure facilities’ compliance with all applicable regulations.
  • Attends routine meetings with the management team for progress reports on projects, facility needs, and discussion of any other required items. Improves current methods and evaluates innovative techniques in quality control testing for edibles products.
  • Promotes an environment that fosters inclusive relationships and creates unbiased. opportunities for contributions through ideas, words, and actions.
  • Performs other related duties as assigned or requested.

EXPERIENCE and QUALIFICATIONS:

  • 3+ years of experience in quality assurance in a cGMP manufacturing environment.
  • Degree directly related to a specialized scientific field preferred.
  • Demonstrated knowledge of all aspects of cGMP.
  • Experience with Food and Drug Administration regulations.
  • Experience within the commercial kitchen or food production environment.
  • Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment.
  • Excellent organizational skills.
  • Attention to detail is an absolute must.

PHYSICAL DEMANDS:

  • Exposure to low humidity environment. 
  • Extremely active and physically demanding; position requires the ability to move quickly and efficiently, ability to push and pull carts, carry items weighing 70+ lbs., ability to lift items overhead; ability to maintain a briskly paced production environment. 
  • Stand for 6+ hours at a time. 
  • Bend, squat, and stoop, twist and bend the neck and waist and reach above and below shoulder height to grasp objects. 
  • Use hands for repetitive grasping, pushing, pulling, and fine manipulation.