Lowell, United States
8 days ago
- Works in a safe manner and follows safety rules at all times.
- Ability to problem solve and communicate issues/resolutions to production management.
- Understands undertakes and implements quality control/assurance techniques and procedures.
- Ability to work with minimal supervision, supports, and drives process improvements and team culture.
- Follows procedures to ensure the production of a quality product.
- Generates product labels to meet production demand.
- Adhere to a production schedule and ensure that materials are stocked and ready for the production day.
- Inspect and ensure that all equipment is calibrated and in working order; balances/scales, pipettes, mediaclave, water purification systems, etc.
- Sanitization and autoclaving of all media production equipment and areas prior to and following production work.
- Performs aseptic techniques while following the SOPs.
- Documents lot numbers, calibration and serial numbers of all equipment used as well as any pre-fill QC; pH, temperature, water resistivity, TOC levels, etc.
- Completes batch process records and ensure they are correct and complete.
- Assist with the execution and documentation of IQ/OQ and PQ processes.
- Maintain and post Manufacturing metrics.
- Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and directives.
- Support immediate supervisor and peers by anticipating problems, providing input on solutions, reacting productively to change and handling other tasks as assigned.
- Experience with automated manufacturing processes is a plus.
- Ability to perform simple maintenance and troubleshoot automated equipment a plus.
- At least 1 year of cleanroom experience required.
- Excellent aseptic process/laboratory skills.
- Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.