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- Successful manufacture of products
- Perform bulk laboratory operations such as fractionation of antiserum, dialysis, filtration, labeling and bottling, using available resources to coordinate daily manufacturing requirements.
- Perform various testing methods such as Heidelberger titers, total protein, OD280, IEP and SDS-Page
- On time Manufacture of products as needed per Planning department
- Perform standard and new operating procedures
- Execute complex laboratory methods per established procedures; support activities to resolve process and testing issues under guidance of senior staff
- Perform procedures involving calculations and material measurements. Collect and evaluate data per defined specifications
- Safely and correctly operate standard laboratory equipment
- Prepare routine solutions and reagents
- Utilize software for data entry and recordkeeping in conformance with company and regulatory policies and standards
- Ensure compliance with all quality and regulatory specifications
- Execute the manufacturing performance metrics (productivity, customer satisfaction and quality improvements)
- Execute on objectives and planned schedules as outlined by supervisor
- Train other lab personnel in established procedures
- Filling, labeling, and packaging of products
- Contribute to completion of specific programs and projects
- Comply with applicable established cGMP, FDA, OSHA, EPA, and Quality System regulations
- Develop, write and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and/or ISO compliance
- Bachelor's degree in a Life Science discipline with related experience, preferred. In lieu of Bachelor's degree in a Life Science discipline, a minimum of 5 years of specific and demonstrated experience may be considered
- Basic knowledge in the use of laboratory techniques such as sterile and aseptic techniques, buffer, and large- and small-scale protein purification
- Demonstrated knowledge in the use of basic scientific laboratory equipment such as pipettes, scales, pH meters, fume hoods, filters, microscopes, BioSafety Cabinets and centrifuges
- Demonstrated knowledge in Sterile / Aseptic technique required
- Demonstrated knowledge in cell culture techniques is required, as well as a basic knowledge of antibody and protein production methods
- Demonstrated ability to follow directions outlined in Standard Operating Procedures; ability to accurately complete Batch Records while adhering to Quality and Regulatory requirements
- Basic knowledge in cell-based assays, and basic immunological/molecular techniques
- Ability to properly and safely handle biologically hazardous materials
- Working knowledge of manufacturing ERP systems, Oracle or SAP preferred
- Good computer skills with proficiency in Office 365 and Excel software applications
- Ability to solve simple and complex mathematical equations
- Ability to multi-task and meet manufacturing production schedules with a sense of urgency
- Good organizational skills and attention to detail
- Good verbal and written communication skills including the ability create clear, concise written reports and accurate completion of batch records
- Ability to follow, write, and edit Standard Operating Procedures
- Adherence to Quality and Regulatory requirements/programs
- Ability to adapt to rapidly changing business circumstances and to thrive in a constantly changing business environment
- Demonstrated knowledge in laboratory safety plans and procedures to ensure compliance with applicable federal, state and local regulations
- Self-directed and self-motivated with the ability to work independently as well as in a team environment
Laboratory Technician - Temecula, United States - Integrated Resources, Inc ( IRI )
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