Documentation Specialist

Job Title: Documentation Specialist

Duration: 6 months, 40 hrs / week

Location: Durham, NC

Qualifications:

Education

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

Required

• 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

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.