FILL AND GEL PREP OPERATOR in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

The Fill & Gel Prep Operator is responsible for preparing gel and fill materials, operating blending and mixing machinery, and ensuring accurate documentation of all batch-related activities. This role supports softgel manufacturing operations by ensuring all materials are prepared, blended, and transferred in compliance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and safety requirements.

• Operate blending and mixing machinery independently and as part of a team to prepare gel mass and fill formulations.

• Prepare, weigh, and verify raw materials accurately according to approved BMRs and manufacturing instructions.

• Perform gel preparation and fill material processing including mixing, blending, heating, and transfer operations.

• Maintain constant attention to manufacturing parameters and batch record documentation throughout production activities.

• Accurately complete all batch manufacturing records, blending logs, and related documentation in compliance with SOPs and GDP requirements.

• Verify labels, materials, and components against batch manufacturing records to ensure accuracy and compliance.

• Monitor equipment and product conditions and immediately report any abnormal conditions, deviations, or safety concerns to management.

• Perform equipment setup, cleaning, and changeover activities in accordance with SOPs and cGMP requirements.

• Handle materials and containers safely, including lifting up to 50 lbs and pushing/pulling containers up to 500 lbs with appropriate equipment.

• Maintain clean, organized, and inspection-ready production areas with proper status labeling of equipment and materials.

• Ensure compliance with all safety procedures, SOPs, and cGMP guidelines to protect self and others in the workplace.

• Support team operations and collaborate with other departments including Quality Assurance, Encapsulation, Maintenance, and Warehouse.

• Perform other duties as assigned by Supervisor / Manager.

• High School Diploma or equivalent required.

• 1–3 years of experience in the pharmaceutical or related manufacturing industry.

• Strong knowledge of cGMP standards and Good Documentation Practices (GDP).

• Ability to read, write, and speak English fluently.

• Excellent writing, communication, and mathematical skills required.

• Experience in blending, mixing, or softgel manufacturing processes preferred.

• Ability to stand and walk for extended periods during the shift.

• Frequent handling of materials, including lifting up to 50 lbs.

• Ability to push/pull heavy containers up to 500 lbs using appropriate equipment.

• Work in environments involving heat, mixing equipment, and manufacturing machinery.

• Softgel pharmaceutical and nutraceutical manufacturing environment.

• Exposure to blending, mixing, and heated processing equipment.

• Required use of Personal Protective Equipment (PPE).

• Overtime and weekend work may be required based on production needs.