Manufacturing Technician-IV

Manufacturing Technician-IV

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

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

Qualifications

Basic Qualifications

• Bachelor of Science degree or equivalent work experience.
• Minimum of 4 years of directly related experience.
• Knowledge of biology and chemistry
• Knowledge of relevant unit operations.
• Sterile cell Culture
• Disposable bioreactors / viral vector manufacturing
• Disposable clarification / filtration (pharmaceutical unit operations)
• Ultrafiltration / Diafiltration
• Skid operation / column chromatography
• Bulk Drug Formulation and dilution
• Sterile Fill / Finish
• Working knowledge of desktop computers and technical equipment