Documentation Specialist I

Company: PSG Global Solutions Careers
Location: Westborough
Posted on: May 25, 2023

Job Description:

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The Opportunity
Description
We're looking for a Documentation Specialist I, working in Pharmaceuticals and Medical Products industry in 1 Research Drive, Westborough, Massachusetts, 01581, United States.

Job description:

• Manage product complaints.
• Review and release production batch records.
• Review manage change controls.
• Provide Quality Review and approval of deviations related to Manufacturing Equipment, Facility and production.
• Participate on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.
• Report metrics and create monthly and quarterly reports.
• Develop Sops as required.
• Perform in accordance with SOPs, safety and GMP guidelines to support release of finished product.
• Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group to develop organizational and technical capabilities.
• Be current with various regulatory requirements and procedures.
  Our Client
  
  Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
  
  Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
  
  Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
  
  Experience Required for Your Success
  
  Requirements:
  • 2 to 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
    What Do You Think?
    Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?

Keywords: PSG Global Solutions Careers, Worcester , Documentation Specialist I, Other , Westborough, Massachusetts