Operations Technician, Compounding Specialist
4 days ago
Key Responsibilities:
- Perform duties associated with the compounding of various commercial and research drug products and formulations
- Complete Pre-Line compounding Activities
- Execute compounding responsibilities (mixer batch, tank batch, & partner batch)
- Document batch records with the utmost attention to detail using cGMP techniques
- Report process deviations to supervisor to prevent product deviations
- Assist with materials management, inventory, logging and tracking as needed
- Perform verifications and calibrations, such as balance, pH and DO
- Review and understand applicable department standard operating procedures and policies
- Assume additional responsibilities as assigned by area management
- Clean rooms and equipment needed for compounding-formulation of the product(s)
- Complete filtration set-up procedures
- Carry-out post line compounding activities
- Conduct filter Integrity Tests
- Transfer Material, API, and components to the compounding-formulation area
- Verify calibration and accuracy of balances and scales
- Set up room and equipment for compounding-formulation and transfer-filtration
- Transfer product(s) aseptically to filling suites
- Operate equipment safely and effectively for production processing
- Ensure all materials, API, and components needed for compounding-formulation are correct per Bill of Material (BOM)
- Update Systems Applications and Products (SAP)
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures
- Wear gowns properly following the standard operational procedures and ensure its integrity during manufacturing activities
- Ensure the integrity of the gown during manufacturing activities
- Inspect equipment to identify any replacements, malfunctions, and repairs
- Preparation of all QA Line clearances required
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures. Gown properly following the standard operational procedures
- Record, maintain and review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance
- Work under the leading guidance of a formulation team leader to perform and complete the assigned duties in a timely manner
- Follow safety procedures and company policies for tasks assigned and equipment operation
- Recommend process improvements to enhance operational efficiency and safety
- Identify and report unsafe operations to Team Leader immediately
- This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA) training within 1 year of hire, and annually thereafter.
- Perform other duties as assigned
- Excellent attention to detail required
- Some working knowledge of FDA Regulations/Guidance's, Good Laboratory Practices, Good Manufacturing Practices, and ICH Guidelines, USP/NF preferred
- Good verbal and written communication
- Organization
- Time-management
- Problem-solving
- Basic mathematics
- Interpersonal and analytical skills
- Flexible work schedule including early hours, required starting shift hours between 3am - 5am
- Physically able to lift 50 lbs and stand for 8 hours
EOE Disability/Veterans Exela Pharma Sciences
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