Documentation Specialist I

4 weeks ago


Westborough, Massachusetts, United States PSG Global Solutions Careers Full time
Job Description

At PSG Global Solutions Careers, we are seeking a highly skilled Documentation Specialist I to join our team in the Biotechnology/Medical Devices industry.

The Opportunity

We are looking for a talented individual to work in a dynamic environment, responsible for managing product complaints, reviewing and releasing production batch records, and providing quality review and approval of deviations related to manufacturing equipment, facility, and production.

Key Responsibilities
  • Manage product complaints and deviations related to manufacturing equipment, facility, and production.
  • Review and release production batch records.
  • Provide quality review and approval of deviations.
  • Participate in team investigations to determine root cause and CAPAs.
  • Report metrics and create monthly and quarterly reports.
  • Develop SOPs as required.
  • Maintain and increase scientific, regulatory, and compliance expertise.
Requirements
  • 2-3 years of experience working in a CGMP environment.
  • Experience working in Quality in a GMP environment.
  • Experience working in a Quality role supporting production.
  • Experience with technical writing.
  • Ability to operate in an environment with strict timelines.
  • Experience performing work that consistently requires decision making and the exercise of judgment and discretion in a CGMP environment.
  • Experience demonstrating written and verbal communication skills.
  • Experience demonstrating proficiency with Microsoft Office applications.
Education
  • BS/BA degree in a scientific discipline.

We are looking for a motivated and detail-oriented individual who can work effectively in a team environment and demonstrate excellent communication and problem-solving skills.



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