GMP Documentation Specialist Position Available In Durham, North Carolina

Job Description:

Job Title:

GMP Documentation Specialist

• VaccineManufacturing Scroll down to find an indepth overview of this job, and what isexpected of candidates Make an application by clicking on the Applybutton. Education
• Bachelor’s degree in Science, Engineering, English, Business,or a related field OR High School Diploma with two years of GMPBiopharma experience.
• Must meet medical clearance requirements for BCG, includingquestionnaire, blood test, and chest x-ray. Required Experience
• Strong knowledge of cGMP regulations and documentationstandards in the pharmaceutical/vaccine industry.
• Experience in reviewing, updating, and maintainingmanufacturing documentation, including batch records, logbooks, andSOPs.
• Ability to work independently and collaboratively withcross-functional teams, including Production, Quality, andTechnical Support.
• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Teamsfor documentation and reporting.
• Excellent critical thinking and problem-solving skills withattention to detail and good documentation practices (GDP). Responsibilities
• Review batch records, logbooks, and electronic documentationfor accuracy and compliance, working closely with production teamsto address errors.
• Support process documentation changes and improvements,ensuring updates to SOPs and batch records align with regulatorystandards.
• Conduct quality reviews of documentation, identifying areas forimprovement and implementing corrective actions.
• Assist with deviation investigations to determine root causesand establish preventive measures for reducing errors.
• Maintain and track documentation metrics to improve shop floorexecution and ensure timely record-keeping.