Manufacturing Specialist
About The Position
This role is within the Manufacturing Services area, specifically in Quality Systems. 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 a 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, as needed by the business. The role involves on-the-floor support, assessing process performance, initiating and approving manufacturing procedures, process troubleshooting, supporting New Product Introduction (NPI), and assisting with Change Control Review Board (CCRB) packages. The ideal candidate will be a multitasker, scientific, and creative, thriving in an environment of 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
- On-the-floor support, assessing process performance through observation of operations and review of performance data
- Initiating, revising, and approving manufacturing procedures
- Process troubleshooting
- New Product Introduction (NPI): assessing documentation, materials, and training requirements
- Supporting change owners on CCRB (Change Control Review Board) packages
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 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
