Career Opportunity: cGMP Manufacturing Associate

Position Summary

The cGMP Manufacturing Associate will be responsible for managing manufacturing and testing related activities for Zynerba Pharmaceuticals Inc. (Zynerba).  The cGMP Manufacturing Associate will work closely with Zynerba personnel, suppliers and contractors to coordinate and execute cGMP activities associated with Zynerba’s pharmaceutical products.  The candidate must have strong Good Manufacturing and Good Documentation fundamentals and must possess strong writing and investigational skills.  This position reports to the Vice President, Manufacturing and will based in our office in Devon, Pennsylvania.

 

Responsibilities

  • Perform cGMP activities such as project tracking, form and logbook entries, purchase order generation, inventory tracking in coordination Zynerba personnel and with third party API and drug product suppliers, test facilities and clinical sites
  • Ensure consistency, completeness, and adherence to FDA, ICH, and ISO regulations
  • Write, revise, execute, track and adhere to Zynerba procedures
  • Assist in the closure of CAPAs, deviations, and investigations as necessary
  • Provide ongoing support to all Zynerba departments as required
  • Complete all associated documentation, and coordinate document control activities
  • Interact with outside suppliers and contractors regarding project activities
  • Track API and drug product shipments between contract organizations
  • Organize and create documentation systems to support Operations and Quality Assurance
  • Keep management informed of all key issues.
  • Employee may perform other related duties as negotiated to meet the ongoing needs of the organization

 

Requirements

  • B.S. or equivalent in Life Sciences, Engineering, or other similar technical field and 3+ years relevant experience in pharmaceutical or medical device industries
  • Working experience in a professional cGMP manufacturing environment
  • Strong documentation skills
  • Experience with pharmaceutical GMP regulations 21 CFR Part 210 & 211 and ICH guidelines is desirable
  • Must demonstrate strong verbal and written communication skills
  • Strong computer skills, MS Word, Excel, Access, MS Project, Visio and PowerPoint

 

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