Documentation Specialist - I

Job Title: Documentation Specialist - I
Location: Onsite – Durham, NC 27712
Job Duration: 07+ Months (Possibilities of Extension)

Shift: Standard Shift
 
Job Summary:
The Documentation Specialist will support vaccine manufacturing operations through accurate and timely documentation practices. This position is part of the Manufacturing Support Team, working directly with shop floor production personnel and interfacing with Technical Support and Quality Operations. The ideal candidate will demonstrate strong attention to detail, a sound understanding of Good Documentation Practices (GDP), and the ability to drive documentation process improvements in a fast-paced GMP-regulated environment.
 
Key Responsibilities:

• Provide comprehensive documentation support for vaccine production activities.
• Review batch records, logbooks, and electronic logbooks for accuracy and completeness.
• Partner with Production, Quality, and other teams to resolve documentation errors and provide clarifications.
• Support updates and improvements to manufacturing documents, including batch records and SOPs.
• Maintain and utilize metrics to track and improve documentation effectiveness on the shop floor.
• Support deviation investigations related to documentation and contributed to meaningful corrective and preventative actions.
• Collaborate cross-functionally to ensure compliance with regulatory and quality standards.
• Use standard software tools such as MS Word, Excel, PowerPoint, Outlook, and Teams effectively.

 
Qualifications:
Education:

• Bachelor’s degree in science, Engineering, English, Business, or related discipline OR
• High School Diploma with a minimum of 2 years of related GMP Biopharma experience

 
Required Skills & Experience:

• Ability to work independently and as part of a team
• Strong critical thinking and problem-solving skills
• Working knowledge of cGMP and regulatory compliance in the vaccine/pharmaceutical industry
• Excellent verbal and written communication skills
• Demonstrated integrity and adherence to company core values: Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

 
Additional Requirements:

• Must complete and be medically cleared for BCG medical clearance (questionnaire, blood test, chest x-ray)