Documentation Specialist
Description:
Position Title: Documentation Specialist
Work Location: Durham, NC 27712
Assignment Duration: 6 months
Work Schedule: M-F 8-5
Notes:
Backlogged documentation. Elogs, RT reports, Electronic batch record operations. Reviewing records, flag (create comment), identifying records need improvements. Quality reviews after. Needs to also keep up w/current documentation
MES, GLIMS, SAP, Veeva Vault heavily preferred
Position Summary: Documentation Specialist will serve on the Manufacturing Support Team working with shop floor production personnel and interfacing with Technical Support and Quality Operations.
Background & Context:
The position requires great attention to detail, a command of good documentation practices (GDP) and the ability to design and strengthen documentation that satisfies Quality requirements.
Key Responsibilities:
Provide documentation support for vaccine production activities
Review batch record, logbooks and electronic logbooks for errors and partner with Production, Quality and other personnel to correct such errors and provide clarification as needed
Support process documentation changes and improvements which includes updates to batch records and standard operating procedures (SOPs)
Effectively maintain and use metrics for the manufacturing shop floor execution documentation program
Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate
Use standard systems including MS Word, Excel, PowerPoint, Outlook, Teams
Qualification & Experience:
Bachelor degree in a Science, Engineering, English, Business or relevant discipline OR Highschool Diploma with two years related GMP Biopharma experience
Work independently and as a Team member with Integrity Precision Accomplishment Motivational Ambition Respect Inclusion
Critical thinking and problem-solving abilities
Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
Working knowledge of documentation administration including the writing, review, and approval of documentation in a GMP industry
Applicant must complete and be medically cleared for BCG medical clearance requirements: questionnaire, blood test, chest x-ray