GMP Documentation Specialist - GMPDS 25-26092

Location: Durham, NC

Duration: 6+ Months (Contract)

Pay Rate: $29/hour

Medical Requirement: Candidates must be medically cleared for BCG clearance (includes questionnaire, blood test, and chest x-ray)

A leading biopharmaceutical organization is seeking a GMP Documentation Specialist to support manufacturing operations. This role is part of the Manufacturing Support Team and will interact regularly with shop floor production personnel, quality teams, and technical support groups. The ideal candidate will be highly detail-oriented, knowledgeable in Good Documentation Practices (GDP), and capable of streamlining documentation processes in a regulated environment.

• Provide end-to-end documentation support for vaccine manufacturing operations.

• Review batch records, logbooks, and electronic records for accuracy; collaborate with cross-functional teams to correct or clarify discrepancies.

• Update and maintain batch records, standard operating procedures (SOPs), and other critical documents.

• Monitor and utilize execution metrics related to documentation workflows.

• Participate in deviation investigations and contribute to immediate and preventive action planning.

• Ensure documentation practices meet internal quality standards and regulatory expectations.

• Use Microsoft Office tools (Word, Excel, PowerPoint, Teams, Outlook) to prepare, update, and manage documentation efficiently.

Education:

• Bachelor’s degree in Science, Engineering, English, Business, or a related discipline
  
  OR

• High school diploma with at least 2 years of relevant GMP experience in biopharmaceutical manufacturing

Required Skills & Competencies:

• Strong attention to detail and a commitment to documentation accuracy

• Familiarity with cGMP standards and regulatory documentation requirements

• Critical thinking and problem-solving capabilities

• Ability to work independently and collaboratively in a fast-paced, regulated setting

• Professional values aligned with Integrity , Precision , Accountability , Respect , and Inclusion

• Experience with authoring, reviewing, and managing documentation in a GMP-regulated industry