Documentation Control Specialist Position Available In Durham, North Carolina

Documentation Control Specialist 3.7 3.7 out of 5 stars Durham, NC 27712

Job Title:

Documentation Specialist –

I/II Job Location:

Durham, NC Job Duration:

6-12

Months Job Description:

The Documentation Specialist will serve on the Manufacturing Support Team, collaborating with shop floor production personnel and interfacing with Technical Support and Quality Operations. The role requires the ability to work efficiently in a fast-paced environment and to be hands-on as needed. Strong attention to detail, a solid grasp of Good Documentation Practices (GDP) , and the ability to design and enhance documentation to meet Quality standards are essential. Provide documentation support for vaccine production activities Review batch records, logbooks, and electronic logbooks for errors; collaborate with Production, Quality, and other departments to correct errors and provide clarification 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 Support documentation-related deviation investigations to identify immediate and preventative actions to reduce deviation occurrences Use standard software tools such as MS Word, Excel, PowerPoint, Outlook, Teams Work with document management and quality systems , including tools like: Veeva (Document Management System) TrackWise (Quality Management) MasterControl (Document & Compliance Management)

Education:

Bachelor’s degree in Science, Engineering, English, Business, or relevant discipline OR High School Diploma with at least 2 years of relevant GMP Biopharma experience

Required:

Ability to work independently and as part of a team with values such as Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion Strong critical thinking and problem-solving skills Working knowledge of cGMPs and applicable regulatory requirements in the vaccine/pharmaceutical industry Experience in documentation administration, including authoring, reviewing, and approving documentation in a GMP-regulated environment Familiarity with tools used in documentation/quality systems (e.g., Veeva, TrackWise, MasterControl, Documentum)

Job Type:

Contract Pay:

$28.00 – $40.00 per hour Expected hours: 40 per week

Benefits:

401(k) matching

Schedule:

Day shift Monday to

Friday Education:

Bachelor’s (Required)

Experience:

Documentation Specialist :

3 years (Required) document management and quality systems: 1 year (Required) Veeva (Document Management System): 1 year (Preferred)

Work Location:

In person