Documentation Specialist - I

Documentation Specialist

Position Description:

The Documentation Specialist provides essential support for vaccine production by ensuring the accuracy, compliance, and continuous improvement of GMP documentation. This individual will work closely with Production, Quality, and Technical Support teams to maintain documentation quality across all manufacturing operations. The role requires strong attention to detail, sound understanding of GMP practices, and the ability to thrive in a fast-paced, collaborative environment.

Key Responsibilities:

• Provide documentation support for vaccine production activities
• Review batch records, logbooks, and electronic logbooks to identify and correct errors in collaboration with relevant departments
• Update and revise process documentation, including batch records and standard operating procedures (SOPs)
• Support process documentation deviation investigations, offering immediate and preventative actions
• Maintain documentation metrics to monitor and improve shop floor execution
• Apply good documentation practices (GDP) and ensure compliance with all applicable cGMP and regulatory requirements
• Assist in the design and improvement of documentation systems to meet evolving Quality standards
• Collaborate with shop floor personnel, Quality Operations, and Technical Support teams to ensure proper documentation control
• Utilize MS Office tools (Word, Excel, PowerPoint, Outlook, Teams) for documentation management

Skills & Qualifications

Required Skills:

• Ability to work independently and collaboratively
• Strong critical thinking and problem-solving abilities
• Working knowledge of cGMPs and regulatory requirements applicable to pharmaceutical/vaccine manufacturing
• Familiarity with documentation systems and practices, including writing, reviewing, and approving documents in a GMP environment
• Excellent written and verbal communication skills
• High attention to detail and a strong understanding of GDP
• Must be able to meet medical clearance requirements for BCG, including questionnaire, blood test, and chest x-ray

Preferred Attributes:

• Experience supporting deviation investigations and documentation change control processes
• Experience in biopharmaceutical or vaccine manufacturing environments

Education:

• Bachelor’s degree in Science, Engineering, English, Business, or a related discipline
• High School Diploma with a minimum of 2 years of relevant GMP biopharma experience also accepted