Documentation Specialist

Documentation Area Specialist ISupport 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.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.The annual salary 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.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 Requirements:GLIMSPAS-XReach Out to a Recruiter:RecruiterEmail: View email address on click.appcast.io: sakshi malviya