GMP Documentation Specialist

Company: Freyr Solutions, Client: Global Pharma company
Location: Durham
Posted on: April 4, 2025

Job Description:

Job Title: GMP Documentation Specialist - Vaccine Manufacturing

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Education
--- Bachelor's degree in Science, Engineering, English, Business, or a related field OR High School Diploma with two years of GMP Biopharma experience.
--- Must meet medical clearance requirements for BCG, including questionnaire, blood test, and chest x-ray.

Required Experience
--- Strong knowledge of cGMP regulations and documentation standards in the pharmaceutical/vaccine industry.
--- Experience in reviewing, updating, and maintaining manufacturing documentation, including batch records, logbooks, and SOPs.
--- Ability to work independently and collaboratively with cross-functional teams, including Production, Quality, and Technical Support.
--- Proficiency in MS Word, Excel, PowerPoint, Outlook, and Teams for documentation and reporting.
--- Excellent critical thinking and problem-solving skills with attention to detail and good documentation practices (GDP).

Responsibilities
--- Review batch records, logbooks, and electronic documentation for accuracy and compliance, working closely with production teams to address errors.
--- Support process documentation changes and improvements, ensuring updates to SOPs and batch records align with regulatory standards.
--- Conduct quality reviews of documentation, identifying areas for improvement and implementing corrective actions.
--- Assist with deviation investigations to determine root causes and establish preventive measures for reducing errors.
--- Maintain and track documentation metrics to improve shop floor execution and ensure timely record-keeping.

Keywords: Freyr Solutions, Client: Global Pharma company, Durham , GMP Documentation Specialist, Other , Durham, North Carolina