What are the responsibilities and job description for the Operations Technician I (1st, 2nd, 3rd Shifts Available) position at Exela Pharma Sciences?
Position Summary
The Operations Technician is responsible for supporting pharmaceutical manufacturing operations including compounding, filling, finishing, and prep activities. This position ensures the production of high-quality pharmaceutical products in compliance with cGMP requirements and FDA regulations through hands-on manufacturing support, equipment operation, and detailed documentation.
Job Responsibilities
- Perform compounding activities including weighing, mixing raw materials, and executing batch operations
- Operate and monitor production line equipment for filling operations and make necessary adjustments per QA requirements
- Execute finishing activities including packaging, labeling, and product inspection for quality assurance
- Complete sterile filtration, steam sterilization, and conduct filter integrity tests
- Perform line changeovers, equipment set-up, and basic troubleshooting
- Document batch records and production documentation with attention to detail using cGMP techniques
- Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMP)
- Collect samples for Quality Assurance testing and report process deviations to supervisors
- Maintain clean room environment and comply with garbing requirements
- Perform equipment calibrations and verifications (balances, pH meters)
- Assist with materials management, inventory tracking, and line clearance activities
- Clean and sanitize equipment and manufacturing areas
- Follow safety procedures and wear required PPE
- Update SAP systems and maintain accurate production records
Experience Requirements
- Excellent attention to detail and basic math skills required
- Good verbal and written communication skills
- Strong organization, time-management, and problem-solving abilities
- Mechanically inclined with ability to troubleshoot equipment issues
- Physically able to lift 50 lbs and stand for extended periods (up to 8 hours)
- Ability to work flexible schedule including early shifts (3am-5am start times)
- Documented vision of 20/20 (corrective lenses permitted) for inspection activities
- Good hygiene and ability to work in clean room environment
- Manufacturing experience preferred but not required
Education Requirements
- High School diploma or equivalent required. Associate degree with scientific background preferred.