Cue Health Inc. is seeking to hire a full-time Production Specialist .
The ideal individual must be detail-oriented, time-organized, able to work in fast-paced lab environments, and take initiative. Under supervision, the Production Specialist will support the scientific and production staff in routine laboratory and production operations, including quality control testing, data and material management, and GMP documentation tasks deemed fit.
- Maintain production documentation and generate routine and ad-hoc reports.
- Documentation review of production work orders.
- Perform root cause analysis of production issues and provide corrective actions.
- Execute Quality Control testing procedures and manage generated data
- Coordinate with Supervisor to implement production plan and determine workflow requirements.
- Prepare and review non-conformance reports to verify investigation and CAPA appropriateness
- Respond to Quality Assurance inquiries and concerns in a timely fashion.
- Conduct clear and concise communication with colleagues (cross-functional) and supervisors through oral updates, written reports, and technical meetings
- Other duties as determined by Management
- BS degree in a science or engineering discipline
- 0.5 - 5 years relevant experience is required in analytical or biochemical based techniques
- Proficient in documentation for production environments
- Excellent communication and collaboration skills
- Extremely detail oriented with excellent organizational skills
- Proven level of high technical proficiency, initiative and independent thought
- Ability to work a schedule which may include weekends or overtime
- Experienced in Process and System Validations concepts and skills
- Knowledge of continuous improvement tools (Six sigma, Lean manufacturing)
- Background in a Science or Engineering discipline with knowledge of Good Laboratory and Manufacturing Practices (GLP/GMP)
- Experience with protein biochemistry and bioprocessing is a plus
- Experience in the Medical Device industry is a plus