Manufacturing Specialist- 08
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 flexible according to business needs. The role requires experience in process engineering, manufacturing support, production systems, process equipment, continuous improvement methodologies, implementing corrective/preventive actions (CAPA), driving process optimization, and understanding compliance and documentation practices for regulated industries. The work environment is described as a lab setting that encourages multitasking, scientific creativity, healthy competition, teamwork, ethical conduct, and the use 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 Process engineering, manufacturing support, or production systems
- Experience with Process equipment, and continuous improvement methodologies
- Experience implementing corrective/preventive actions (CAPA)
- Experience driving process optimization
- Experience with Compliance, and documentation practices for regulated industries
Nice To Haves
- Multitasking skills
- Scientific creativity
- 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, 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
