Training & Documentation Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)
  3. United States
Princeton, USA
Posting date: 09 Apr 2021

Proclinical is currently recruiting for a Training & Documentation Specialist for an exciting and rapidly growing biopharmaceutical company in New Jersey. As the Training & Documentation Specialist you will be a key member of the QA team, supporting activities which have a focus on coordinating GxP training and documentation.

Job Responsibilities:

  • Ensuring work is performed per GxP regulations and guidelines.
  • Co-ordinating training for employees and ensuring procedures and policies are written, reviewed and approved.
  • Assisting in the development and organization of GMP documentation and records.
  • Maintaining and tracking training and documentation metrics and trends.
  • Assisting with the planning and preparation of internal and external GxP audits.
  • Conducting reviews of documentation including; batch records, OOS investigations, complaints, etc.

Skills and Requirements:

  • Bachelor's Degree in Lifesciences or related field
  • Previous experience in QA in a manufacturing environment
  • Proficiency with Quality Management Systems - ideally Trackwise

If you are having difficulty in applying or if you have any questions, please contact Alex Tooulas at (+1) 917-284-9670 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.