Manufacturing Specialist- 11
About The Position
For Manufacturing Services in the Quality Systems area. This role requires a Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry. The ideal candidate will be bilingual (English & Spanish), possess strong Project Management skills, and be comfortable working an administrative shift according to business needs. Experience in Root Cause Analysis methodologies, Lean Manufacturing, and GDP Practices is essential. Familiarity with various software and platforms such as Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms is required. The role thrives in an environment that values multitasking, scientific rigor, creativity, 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 Root Cause Analysis methodologies
- Experience in Lean Manufacturing and GDP Practices
- Experience with Trackwise, VEEVA, MES, Smart Sheet, ChatGPT, Copilot, Power BI, Spotfire, CDOCS, and process monitoring platforms
Responsibilities
- Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions.
- Provide troubleshooting support.
- Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
- Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
- Provide support of timely execution of the process monitoring quarterly reports.
- Ensure that all Non-conformances are triaged within the established goal.
- Responsible for authoring investigation reports.
- Responsible for execution of corrective actions.
- Responsible for managing NC/CAPA closure within established goal.
- Monitor and communicate incidents 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
