Manufacturing Specialist
About The Position
This role is within the Manufacturing Services area, specifically in Quality Systems. The ideal candidate will have a Bachelor's Degree with five years of experience as a Scientist in a pharmaceutical or regulated industry. Bilingualism 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 deviations/non-conformances investigations, technical writing and report development, root cause analysis tools (such as causal factors analysis, 5 Why’s), and identifying/tracking actions to meet due dates. The company fosters a collaborative and ethical environment that values the scientific method, teamwork, and healthy competition.
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 Deviations/non-conformances investigations
- Experience in Technical writing and development of reports
- Experience with Root cause analysis tools (e.g. causal factors analysis, 5 Why’s)
- Experience in Identifying/tracking actions and achieving due dates
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.
- 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 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
Entry Level
