GMP Manufacturing Operator

Job Title: GMP Manufacturing Operator – Freeze/Thaw Operations Location: 100% Onsite Duration: 3 Months Shift: 1st Shift (Monday–Friday) Working Hours: 8:00 AM – 5:00 PM Interview: 30-minute Microsoft Teams Interview Job Summary We are seeking a GMP Manufacturing Operator to support Freeze/Thaw campaign activities in a controlled manufacturing environment. This role is responsible for executing manufacturing and material handling operations while working in temperature-controlled cold rooms. The ideal candidate will follow GMP procedures, electronic batch records, and site documentation requirements while maintaining compliance with safety and quality standards. Key Responsibilities Perform Freeze/Thaw manufacturing operations following approved SOPs, work instructions, and GMP requirements. Work in temperature-controlled environments, including 2–8°C and -40°C cold rooms. Execute manufacturing activities using PAS-X Electronic Batch Records (EBR). Complete electronic batch records accurately and ensure compliance with documentation requirements. Follow all training requirements, SOPs, and Read & Sign documentation. Maintain compliance with GMP, safety, quality, and regulatory standards. Support audit-ready manufacturing operations through accurate documentation and procedural compliance. Work collaboratively with trainers and manufacturing personnel during onboarding and operational activities. Maintain required system access and operator qualifications throughout the assignment. Follow material handling procedures while supporting campaign readiness and execution. Training Comprehensive onboarding and training will be provided over approximately 3.5–4 weeks, including: PAS-X Electronic Batch Record (EBR) Operator Training Freeze/Thaw Operations Training Shipping & Freeze/Thaw Basics On-the-Job Training (OJT) SOP and Read & Sign documentation System access and qualification requirements Required Systems PAS-X SAP Freeze/Thaw Operator Systems Preferred Qualifications High School Diploma or GED required. 1–2 years of experience in a GMP manufacturing environment. Experience working in pharmaceutical, biotechnology, or regulated manufacturing environments. Familiarity with electronic batch records (EBR), preferably PAS-X. Experience following SOPs, GMP documentation, and quality procedures. Comfortable working in refrigerated and freezer environments for extended periods. Strong attention to detail, documentation accuracy, and adherence to safety procedures. Ability to work independently and as part of a team in a fast-paced manufacturing environment. Preferred Skills GMP Manufacturing Freeze/Thaw Operations Electronic Batch Records (EBR) PAS-X SAP SOP Compliance GMP Documentation Material Handling Cold Room Operations Quality & Compliance Pharmaceutical Manufacturing Biotechnology Manufacturing Attention to Detail Team Collaboration JC - R6 Employment Type: Full Time Salary: $25 - $28 Hourly Bonus/Commission: No