Documentation Specialist Position Available In Durham, North Carolina

Job Description

Documentation Specialist Contract:

Durham, North Carolina, US Salary Range:

25.00 – 29.00 |

Per Hour Job Code:

361353

End Date:

2025-05-24

Days Left:

28 days, 3 hours left About the Role We are seeking a dedicated Documentation Specialist to join our Manufacturing Support Team.
This role involves working closely with shop floor production personnel and interfacing with Technical Support and Quality Operations.
The ideal candidate will thrive in a fast-paced environment and demonstrate a hands-on approach when necessary.
Attention to detail, a strong command of good documentation practices (GDP), and the ability to design and enhance documentation to meet Quality requirements are essential for success in this position.

Pay Range:

$25 -$29 Responsibilities – Provide documentation support for vaccine production activities.
Review batch records, logbooks, and electronic logbooks for errors, collaborating with Production, Quality, and other personnel to correct and clarify as needed.
Support process documentation changes and improvements, including updates to batch records and standard operating procedures (SOPs).
Maintain and utilize metrics for the manufacturing shop floor execution documentation program effectively.
Support process documentation deviation investigations to provide meaningful immediate and preventative actions and reduce the deviation generation rate.
Utilize standard systems including MS Word, Excel, PowerPoint, Outlook, and Teams. Education Qualification- Bachelor’s degree in Science, Engineering, English, Business, or a relevant discipline OR a High School Diploma with two years of related GMP Biopharma experience. Required Skills – Ability to work independently and as a team member with integrity, precision, accomplishment, motivational ambition, respect, and inclusion. Strong critical thinking and problem-solving abilities.
Working knowledge of cGMPs and regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Familiarity with documentation administration, including writing, reviewing, and approving documentation in a GMP industry.
Completion and medical clearance for BCG medical clearance requirements: questionnaire, blood test, chest x-ray.
Job Requirement
Documentation
batch records
standard operating procedures (SOPs)
Reach Out to a Recruiter
Recruiter
Email
Phone
sakshi malviya
sakshi.malviya@collabera.com