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Compliance Coordinator - (Health & Beauty Manufacturing)

    • Job Tracking ID: PGX03
    • Job Location: Morgantown, PA
    • Job Level: Mid Career
    • Level of Education: BA/BS
    • Job Type: Full-Time/Regular
    • Date Updated: August 02, 2023
    • Years of Experience: 5 - 7 Years
    • Starting Date: ASAP
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Job Description:

Compliance Coordinator

(Health & Beauty Manufacturing)

 


We are seeking a full-time and permanent Compliance Coordinator to join our Team at PhytogenX in Morgantown, PA. This role reports into the Director of Quality.

 

Job Responsibilities/Duties:

The Compliance Coordinator will have overall responsibility for ensuring PhytogenX personnel, processes, and equipment comply with current Good Manufacturing Practices (cGMP) as outlined in 21 CFR 210 and ISO 22716.

  • Liaise with all relevant departments to ascertain current compliance levels
  • Provide training and education to team members regarding cGMP
  • Ensure that all team members are aware of the procedures to be followed to adhere to compliance requirements
  • Organize and conduct internal audits and follow-up on any audit related corrective actions
  • Coordinate external regulatory and customer audits and complete requested self-assessments/questionnaires
  • Organize, perform, and track the environmental monitoring program of the facility
  • Oversee the maintenance and performance of the USP water system
  • Organize, perform, and track IQ/OQ/PQ and validation on all production and quality related equipment
  • Organize and monitor the equipment calibration program
  • Oversee the pest control program
  • Maintain and update FDA product registrations and applicable state manufacturing registrations
  • Coordinate and delegate compliance related tasks for the Compliance Analyst

 

 

Experience and Skills:

 

  • We prefer a Bachelor’s degree in Chemistry, Biology, or other scientific discipline with 3-5 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
  • Or a Associates degree in Chemistry, Biology, or other scientific discipline with 5-7 years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
  • Or a High School Diploma, or equivalent, with 7+ years of regulatory or compliance experience in a cosmetic, pharmaceutical, or biotechnology related industry
  • Strong knowledge or understanding of cGMP requirements
  • Strong organizational skills and attention to detail
  • Ability to multitask and adjust priorities
  • Computer skills/MS Office proficiency
  • Good communication skills and an ability to work in a fast-paced environment

 


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