Temporary to Fulltime - opportunity
Responsible for the manufacture of prototype, pilot, and production kit reagents per written instructions. Responsible for sub-assembly formulation, raw material prep and/or processing. Support in-process testing when necessary. Participate in transfer, support activities and continuous improvement on existing processes. Keep accurate records and documentation. Maintain laboratory under cGMP conditions.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assist in maintaining laboratory stock of general raw materials and lab supplies for daily use
- Writes, reviews and approves manufacturing instructions and SOPs as needed
- Reviews notebook studies, technical reports and prototype documents
- Assists with the creation/revision of product routings
- Able to perform greater than 70% of the manufacturing activities in the department
- Maintain laboratory to cGMP regulations
- Generate non-conformance reports
- Participate in continuous improvement ideas from inception to completion
- Trains new employees as necessary
- Troubleshoots standard manufacturing process problems with management
- Assist in execution of Installation, Operational, and Performance Qualifications
- Responsible for the efficient organization and utilization of time within the workday
- Establishes effective working relationships with other departments such as Quality, QC, etc.
- Perform all laboratory assignments in accordance with established safety procedures in assigned laboratory or work area.
- Performs other related duties as assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Professional growth opportunity exists as development projects from Research and Development grow into routine manufactured products in the next few years.
Job Requirements :
EDUCATION and EXPERIENCE
- BS in Science. Prefer molecular biology, biochemistry, or chemistry.
- Two to four years of biotechnology experience, with technical understanding and experience in one or more manufacturing areas.
- Extensive knowledge of laboratory procedures, established techniques, instruments and equipment as a result of laboratory training. cGMP experience required.
- Good presentation and technical writing skills.
Roka Bioscience - 2 years ago