Title: Technician, Manufacturing 4
Duration: 12 Months
Location: Carlsbad, CA
Work hours: In general, hours are 8:00 am - 5:00 PM, the employee must be able to work off-shifts, weekends, and additional hours as required.
Essential Job Functions
- Troubleshooting equipment and process failures
- Recognize common equipment failures and process anomalies
- Assist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.
- Author Document Change Requests for Batch Production Records, Standard Operation Procedures, Item Specifications, and Qualifications.
- Leadership
- Reinforce cGMP documentation guidelines
- Emphasize importance of quality cGMP compliant documentation to coworkers
- Provide on-the-job training, emphasizing cGMP compliance
- Provide a positive reinforcing, open learning atmosphere
- Tailor training style to meet individual needs
- Set a good example in observance of cGMP and Quality
- Follow up on instructions/suggestions to ensure compliance
- Demonstrate leadership by example and participation
- Compliance with safety guidelines
- Use safety eyewear while inside a manufacturing area
- Know appropriate emergency response procedures
- Know locations of first aid kits, safety showers, spill kits
- Know evacuation route and assembly area to be used in case of fire or earthquake
- Know the location of MSDS binders and understand how the guidelines pertain to operations
- Follow good chemical safety practices
- Comply with all cGMP Documentation and procedures
- Record information accurately
- Make corrections in a timely manner
- Check all necessary calculations
- Review pre-recorded data for accuracy and completion
- Ensure all entries are neat and legible
- Understand operator and verifier responsibilities
- Review labels and equipment calibrations prior to use
- Perform preliminary review of completed documentation
- Keep logbooks updated and accurate
- Comply with cGMP Practices and Regulations
- Generate clear and concise labels for all in-process equipment and materials
- Understand, observe, and practice proper gowning
- Understand flow of materials and personnel in the manufacturing areas
- Maintain clean and well-stocked labs
- Technology transfer
- Assist in the introduction of manufacturing schemes into the GMP manufacturing facility
- Assist with the purchase of equipment required for new processes
- Lead the startup and validation of new equipment with the assistance of the Validation group
- Author the Standard Operation Procedures required to incorporate new production equipment into the manufacturing facility.
- Provide all the necessary training required to incorporate new production equipment into the manufacturing facility.
- Supervise, and perform as needed, the creation and revision of production documents in order to maintain cGMP compliance and efficiency
- Demonstrate consistent initiative in generating documents and in providing revisions for all documents
- Supervise, and perform as needed, employee training
- Ensure that training records are reviewed and regularly updated
- Reinforce cGMP documentation guidelines
- Provide instruction and guidance to coworkers to prevent errors
- Oversee and maintain the departmental training program
- Implement innovative training programs
- Communicate with members of the manufacturing group, and with other departments, as needed to optimize the production schedule
- Provide frequent detailed operations updates to the appropriate members of the Manufacturing group
- Hold operations meetings regularly to establish flow of information
- Effectively and consistently prioritize and delegate daily assignments and projects to the Biologists and Technicians. Ensure that all staff understand, properly prioritize, and execute their assignments
- Write and distribute concise and effective memos, reports, and communiques as required
- Openly address internal audit items to the shift in an appropriate and timely manner
- Compliance with Policies and Regulations
- Compliance with 21 CFR - Parts 210 and 211
- Compliance with SOPs, batch records, forms, logs of use