Manufacturing Specialist- 03
About The Position
This role is within the Quality Systems area of Manufacturing Services. The ideal candidate will have a Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual in English and Spanish is required, along with strong Project Management skills. The position involves administrative shifts and is flexible according to business needs. Experience with change controls for manufacturing, deviation investigations, determination of Corrective/Preventive Actions (CAPA), and Risk Assessments is essential. The role requires a blend of multitasking, scientific, and creative skills, operating within an environment that values healthy competition, teamwork, ethics, and the scientific method.
Requirements
- Bachelor's Degree
- Five (5) years of experience as a Scientist within the pharmaceutical or regulated industry
- Bilingual (English & Spanish)
- Project Management skills
- Experience in change controls for manufacturing
- Experience in deviation investigations
- Experience in determination of Corrective/Preventive Actions
- Experience in Risk Assessments, CAPA
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 provide 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.
- Author investigation reports.
- Execute corrective actions.
- Manage NC/CAPA closure within the established goal.
- 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
Mid Level
