Documentation Specialist

Documentation Specialist - I

Location: 100 Rodolphe Street, Durham, NC Pay Rate: $29.5/HR

Qualifications:

Education: Bachelor degree in a Science, Engineering, English, Business or relevant discipline OR Highschool Diploma with two years related GMP Biopharma experience Required

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

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

Documentation Specialist will serve on the Manufacturing Support Team working with shop floor production personnel and interfacing with Technical Support and Quality Operations and must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation. 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.

Comments/Special Instructions

2 Positions 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.

Kindly share your resume with answers: Q1: How many years of exp in cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry Q2: Do you have exp in documentation administration including the writing, review, and approval of documentation in a GMP industry Q3: Any exp in documentation support for vaccine production activities Q4: Do you have exp in Electronic batch record operations. Q5: how far you live and how will you commute to 100 Rodolphe Street, Durham, NC