Job Title: Manufacturing Specialist
Location: Remote
We are seeking a dedicated and experienced Manufacturing Specialist. This role is integral to our mission of delivering high-quality products to our customers. The successful candidate will be responsible for providing insightful data analysis and ensuring the smooth execution of tasks across our client’s external manufacturing network.
Job Responsibilities:
- Conduct comprehensive data analysis and provide valuable insights to facilitate efficient operations across our client’s external manufacturing network.
- Guarantee the accuracy and completion of data entries for the development, monitoring, and reporting of budgets.
- Regularly report on contract site performance metrics, identifying areas for improvement and proposing actionable solutions.
- Coordinate, issue, and review meeting minutes, conclusions from data analysis, and standardization of performance tools.
- Actively engage in Work Center Teams (WCT) meetings with the contract site and internal site team, contributing to discussions and decision-making processes.
- Oversee department-wide projects from inception to implementation, identifying potential risks and coordinating risk management activities.
Skills and Qualifications:
- A minimum of 5 years of experience in a Good Manufacturing Practice (GMP) environment, with a preference for experience in manufacturing processes, particularly upstream in drug substance.
- Profound knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
- Proven experience in managing quality records, including NC Class II/III records, Corrective and Preventive Actions (CAPA), CAPA Effectiveness Verification (CAPA EV), and complex change control records.
- Demonstrated team leadership and facilitation skills.
- Flexibility to work varying hours to support global operations.
- Educational background: Doctorate degree OR Master’s degree with 3 years of experience OR Bachelor’s degree with 5 years of experience OR Associate degree with 10 years of experience OR High school diploma / GED with 12 years of experience.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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