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Documentation Specialist
Contract: Durham, North Carolina, US
Salary Range: 30.00 - 33.00 | Per Hour
Job Code: 370791
End Date: 2026-08-28
Days Left: 5 days, 3 hours left
Position Details:-
Title: Documentation Area Specialist I
Duration: 6 Months
Location: Durham NC
PURPOSE:
- Support daily GMP manufacturing operations by performing production sampling, managing batch documentation and GLIMS activities, and coordinating with cross-functional stakeholders to ensure accurate, timely, and compliant execution of manufacturing processes that enable product quality and batch release.
ESSENTIAL FUNCTIONS:
- Create production batches and print labels in GLIMS to support daily manufacturing operations.
- Print and review paper batch records to ensure accuracy, completeness, and GMP compliance.
- Enter GMP production data into GLIMS accurately and in a timely manner to support batch release activities.
- Aliquot production samples and deliver them to the Quality Control (QC) laboratory on time, ensuring right-first-time execution.
- Coordinate and communicate daily sampling schedules with stakeholders using the sample tracker, escalating issues as appropriate.
- Coordinate requested sample shipments to Denmark on an as-needed basis, ensuring compliance with applicable procedures and timelines.
- Collaborate effectively with cross-functional team members and local colleagues to support production and quality objectives.
- Perform minor document revisions and updates in accordance with document control procedures.
- Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) while performing assigned responsibilities.
- Adhere to all safety, environmental, and company policies in the performance of assigned duties.
- Wear and safely operate a Powered Air-Purifying Respirator (PAPR) as required during sampling activities.
- Maintain clear, professional communication with internal stakeholders to ensure timely resolution of production and sampling issues.
- Support daily production operations by completing assigned tasks accurately, efficiently, and within established timelines.
- Perform other related duties as assigned to support manufacturing and quality operations.
Salary and Other Compensation:
The annual [salary/hourly rate] for this position is between $30.00 - 33.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements:
[medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance],
[paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].
Job Requirement
- GLIMS
- PAS-X
Reach Out to a Recruiter
- Recruiter
- Phone
- sakshi malviya
- sakshi.malviya@collabera.com
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