JT251 - SPECIALIST MANUFACTURING
Quality Consulting Group View all jobs
- Juncos, PR
- Permanent
- Full-time
- Support the execution of manufacturing such as non-conformances, process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
- Initiate, revise, and approve manufacturing procedures.
- Serve as a document owner.
- Evaluate, plan, and implement solutions for process improvement opportunities.
- Provide troubleshooting support.
- Provide support of timely execution of the process monitoring quarterly reports, Non-Conformance and CAPA.
- Ensure that all Non-conformances are triaged within the established goal.
- Responsible for authoring investigation reports.
- Responsible for execution of corrective actions.
- Responsible for managing NC/CAPA closure within established goal.
- Monitor and communicate incidents trends.
- Review equipment/system Root Cause Analysis investigations and support trend evaluations.
- Assist with generation of process validation protocols and reports.
- Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
- Assist manufacturing change owner on CCRB packages impacting the process.
- Participate on the assessment or implementation of special projects or initiatives.
- Bachelor's degree in science or industrial engineering preferred
- 4 years of Manufacturing Operations experience
- 4 years of Manufacturing Operations experience
- Proficient and experienced in owning Change Controls.
- Demonstrated ability in Deviations documentation.
- Project Management and/or Quality Management skills and experience.
- Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
- Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system
- Available for administrative shift and OT based on business needs