Manufacturing Specialist- 10
About The Position
This role is for the Manufacturing Services department, specifically within the Inspection area. The ideal candidate will possess a Bachelor's Degree with five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual proficiency in English and Spanish is required, along with strong Project Management skills. The position involves non-standard shifts according to business needs. Key responsibilities include experience with CAPA/CAPA EV, Change Control, developing new procedures, implementing new processes, modifying existing SOPs, and providing training to operators. The ideal candidate will be a multitasker with scientific and creative skills, thriving in an environment of healthy competition, teamwork, ethical conduct, and the application of 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 CAPA/ CAPA EV, Change Control, develop new procedures
- Experience in Implement new process, modify the current SOP’s, Provide training to operators
Nice To Haves
- Multitasking skills
- Scientific skills
- Creative skills
- Ability to work in an environment of healthy competition
- 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 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.
- Responsible for authoring investigation reports.
- Responsible for the execution of corrective actions.
- Responsible for managing 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
Senior
