Change Control Specialist- 02
About The Position
This role is within the Quality Systems area for 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. Experience in Change Control & Compliance, Process validation protocols and reports, and New Product Introduction & Batch Records is essential. The role requires a candidate with multitasking, scientific, and creative skills, who thrives 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 Change Control & Compliance
- Experience in Process validation protocols and reports
- Experience in New Product Introduction & Batch Records
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, evaluating, planning, and implementing 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.
- 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
