Documentation Specialist

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].