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Training & Documentation Specialist
- Permanent
- Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)
- United States
This vacancy has now expired. Please see similar roles below...
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 a.tooulas@proclinical.com.
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.
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