The Technician, Operations - Compounding will be responsible for assisting with the compounding activities of manufacturing solutions and suspensions: Weighing, adding, and mixing raw materials, sterile filtration, steam sterilization, sanitation, and documentation activities associated with the production of drug products. This position supports the ongoing development, manufacture, and distribution of pharmaceutical products in compliance with local procedures, corporate policies, and the regulatory requirements of the U.S. Food and Drug Administration.
Job 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
Required Skills:
- 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
Education and Experience Requirements
- High School diploma/ or equivalent required. Associate degree with scientific background preferred.
EOE, including disability/vets.
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