Manufacturing Specialist- 07
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. Experience with Drug Substance processes, GMP pharmaceutical manufacturing systems, and various software systems including SAP, TrackWise, electronic batch records (PAS/X), and document management systems (Veeva) is essential. The role also requires a proactive and collaborative personality, comfortable in a lab environment, with a strong adherence to teamwork, ethics, and 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 Drug Substance processes
- Experience in GMP pharmaceutical manufacturing systems
- Experience with SAP, TrackWise, electronic batch records (PAS/X), and documents management systems (Veeva)
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 potentially 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
Senior
