Manufacturing Specialist
Flexible & Integrated Technical Services, LLC•Juncos, PR
•Onsite
About The Position
This role is within the Manufacturing Services area, specifically in Quality Systems. The ideal candidate will possess a blend of technical expertise and personal attributes suited for a dynamic, team-oriented environment. The position involves a significant amount of hands-on work, problem-solving, and adherence to scientific methods within the pharmaceutical or regulated industry.
Requirements
- Bachelor's Degree with four (4) years of experience as a Scientist within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Experience in Change Control processes, with hands-on expertise assessing supplier-related quality records.
- Experience with TrackWise and SAP.
- Experience in Non-conformance/CAPA investigation authoring and closure management.
- Experience in Process validation protocols, execution, and data analysis.
Nice To Haves
- Multitasking skills.
- Scientific skills.
- Creative skills.
- Ability to work in an environment of healthy competition and teamwork.
- Ethical conduct.
- Use of the scientific method.
Responsibilities
- Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations and serving as a document owner.
- Assess process performance through observation of floor operations and review of performance data, then evaluate, plan, and implement solutions.
- 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 the establishment of process monitoring parameters and control limits, collect process-monitoring data, and support the assessment of deviations.
- Provide support for the timely execution of 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 goals.
- Monitor and communicate incident trends.
- Review equipment/system Root Cause Analysis investigations and support trend evaluations.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
