GMP Specialist

Job ID 18-00093

Industry Pharma

Job Type Permanent

Location Somerset, NJ


Job Description:

  • Leadership role in site compliance Operations meetings.
  • Conducts GMP training with materials approved by Quality.
  • Responsible for follow ups on all related Operational findings from FDA, other regulatory bodies, contract customers, internal audits, etc.
  • Room checklist and logbook program oversight in accordance with approved SOP's.
  • Leadership for and conducting of daily walk-throughs for GMP potential concerns; and subsequent reporting and tracking to closure.
  • Assures area management is accountable for compliance at all times with direct, independent reporting relationship to site head.
  • Follow up and support investigations assigned to site Operations.
  • Jointly responsible for CAPA development with area HODs and implementation of action plans along with tracking of KPIs.
  • Special assignments from site head relating to GMP compliance
  • Conduct weekly facility walk through evaluations with facility maintenance
  • Review employee practices for proper aseptic techniques, including media fill videos.
  • Provide daily oversight to Production Supervisors and Team Leads of all documentation within the formulation, filling and packaging departments. This is to assure effective detection and real-time corrective action of operator errors.
  • Conduct aseptic behavior training in concert with Quality.
  • Assist in media fill program and observer role.
  • Standing member of site Technical Review Board.


Education and Experience:
Bachelor Degree in Scientific Discipline or equivalent combination of education and experience
5 years minimum work experience in Aseptic Manufacturing for a FDA regulated and approved facility
Excellent oral and written communication skills

Job Prerequisites:
Hands on experience required to manage and trouble shoot major projects.
Have a thorough knowledge in applicable FDA/cGMP and ICH guidelines.
Skilled in presentation to and interface with senior level management.

Candidate Details:
5+ to 7 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel – Never