Production Specialist

Responsibilities

• Main point of contact for Track Wise (TW) related activity associated with Primary Production.
• Aids in the timely execution of Production projects, manages employee work schedules and production needs.
• Ensures adherence to cGMPs, Praxis’ SOPs, policies and work instructions.
• Manages new and existing customers within the systems.
• Communicates equipment issues and works to prevent and reduce downtime.
• Ensures line processes and procedures are established and followed.
• Deploys additional serialization lines as applicable.
• Ensures all personnel working on the line receive adequate training.
• Works with IT to resolve any technical difficulties that may arise.
• Ensures the line is staffed and ready to run per the established schedule.
• Sends out status updates routinely and as issues arise to management personnel.
• Investigates deviations related to Primary Production.
• Facilitates TW change controls related to Primary Production.
• Serves as backup to the Primary Production manager in any TW related meetings or cases.
• Aids with project management, ensuring projects are completed by established deadlines.
• Contributes as a subject matter expert (SME) in applicable projects related to Primary Production.
• Adheres to all Company policies and procedures.
• Improves the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Provides assistance and answers a diverse workforce of 5-10 employees.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Affords support and answers a diverse workforce of 5-10 employees.
• Assists with Training and Orientation.
• Ensures employees are trained according to their roles.
• Elevates complaints and problems, seeks Management assistance.
• Ensures proper PPE’s and Safety procedures are followed.

Qualifications

• High school diploma or equivalent required.
• Associates Degree or equivalent combination preferred.
• 2-4 years plus similar experience required.
• Strong GDP/GMP experience required.
• Led/Group Leader experience preferred.
• Basic Mechanical and mathematical aptitude required.
• The ability to work independently, without supervision required.
• The ability to organize priorities and workload required.

Pay

USD $55,000.00 - USD $75,000.00 /Yr.