Manufacturing Specialist- 11
About The Position
This role is within the Quality Systems area of Manufacturing Services. The ideal candidate will possess a strong technical background with a Bachelor's Degree and at least five years of experience as a Scientist in the pharmaceutical or regulated industry. Bilingual proficiency in English and Spanish is required, along with strong Project Management skills. The position operates on an administrative shift, adaptable to business needs. Key experience areas include Manufacturing Operations, continuous improvement methodologies, troubleshooting manufacturing issues, implementing corrective/preventive actions (CAPA), driving process optimization, and understanding compliance and documentation practices for regulated industries. The role also requires a proactive and collaborative personality, with a knack for multitasking, scientific thinking, and creativity, thriving in an environment of healthy competition, teamwork, ethical conduct, and scientific rigor.
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 Manufacturing Operations
- Experience in Continuous improvement methodologies
- Experience in troubleshooting manufacturing issues, implementing corrective/preventive actions (CAPA), and driving process optimization
- Experience in compliance and documentation practices for regulated industries
Nice To Haves
- Multitasking skills
- Scientific skills
- Creative skills
- Ability to work in an environment of healthy competition and 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, then evaluate, plan, and implement solutions.
- Provide troubleshooting support for manufacturing issues.
- 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
Mid Level
