Manufacturing Specialist- 05
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 operates on an administrative shift, adaptable to business needs. Experience with Root Cause Analysis methodologies, Lean Manufacturing Practices, and Good Documentation Practices (GDP) in a regulated environment is essential. Familiarity with systems/tools such as Trackwise, VEEVA, MES, Smart Sheet, and ChatGPT is also required, along with strong writing and presentation abilities. The role thrives in a collaborative, ethical, and scientifically rigorous environment, encouraging creativity and teamwork.
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 Root Cause Analysis methodologies
- Experience in Lean Manufacturing Practices
- Experience in GDP (Good Documentation Practices) on a regulated environment
- Experience with Systems/Tools: Trackwise, VEEVA, MES, Smart Sheet, ChatGPT
- Writing/presentation abilities
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 provide training on scientific or technical aspects of the process.
- Support the establishment of process monitoring parameters and control limits, collecting process-monitoring data and supporting 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
