Specialist Manufacturing
Flexible & Integrated Technical Services, LLC
- Juncos, PR
- Permanent
- Full-time
- Bachelor's Degree with five (5) years of Manufacturing Operations experience within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.
- Experience in:
- Floor
- Procedures review and approval
- Change Control
- CAPA
- Problem Solving
- We know you know the Manufacturing language to perfection, but how about talking with Process Development? And Quality? And any and all other areas in the industry? If you’re confident in those communicating skills of yours and give value to teamwork, the scientific method and, above all else, being ethical, then this might be the job for you! Bring it on!
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Provide troubleshooting support.
- Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
- Provide support of timely execution of the process monitoring quarterly reports.
- 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.
- Assist with generation of process validation protocols and reports.
- Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.