Manufacturing Specialist- 06
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 (English & Spanish) skills and Project Management experience are required. The position involves administrative duties and is scheduled according to business needs. The role requires experience in change controls for manufacturing, deviation investigations, determination of Corrective/Preventive Actions, Risk Assessments, and CAPA. The ideal candidate will be a team player, ethical, and proficient in using the scientific method, with strong multitasking, scientific, and creative skills.
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
- Experience in CAPA
Nice To Haves
- Multitasking skills
- Scientific skills
- Creative skills
- Ability to work in an environment of healthy competition and teamwork
- Ethical conduct
- Proficiency in using 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.
- 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
Senior
