Syringe Process Manager

Job Title: Syringe Process Manager

Location: Swiftwater, PA

Shift: 3rd Shift – 10:00 PM to 6:30 AM, either Sunday through Thursday or Tuesday through Saturday, to be determined based on business needs.

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Responsible for overseeing personnel and activities associated within their shift and ensuring team adherence to all +QDCI standards. Drive continual improvement of line performance through leading and supporting projects and initiatives including investigations into deviations from planned outcome and associated CAPA to prevent reoccurrence.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Production management through leading, scheduling, planning, and use of all key process systems such as eOOE, iObeya, Qualipso, SAP, and Ocularis. 20%

• Lead critical functions including, but not limited to, 5W2H’s, Gembas, MSV, LSV’s, real time reviews, BFR, Sartocheck, Paltronic, and Ops Tracker audits 20%

• Process improvement and project work 30%

• Coordinating with supporting agencies and lead meetings to achieve all +QDCI standards 10%

• Assist with PCU development and training 10%

• Personal training and development 10%

Context of the job/major challenges

• Manages the process within the shift to meet goals and priorities. Assures operations are conducted in compliance with regulatory authorities. Assures operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies.

• Plans and initiates the overall production schedules and coordinates personnel activities with other manufacturing staff.

• Reviews batch records for correctness and completeness.

• Overall responsibilities include employee selection, training, development, counseling recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets.

• Chief duty involves providing managerial coverage for employees as required during assigned shift hours.

• Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, Management Committee, staff meetings), and work unit teams.

• When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders.

• Takes a role in implementing new equipment and procedures.

• Performs all other duties as required by department management.

• Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required.

• Background in Aseptic Processing is favorable.

Dimensions/Scope

This role is for an exempt employee working in the Filling Department.  Their Bi-weekly pay is based on previous experience and education time. 

Their responsibilities are, but are not limited to:

Safety:

• Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings

• LSVs and MSVs

• Reports all safety issues, concerns, incidents and near misses to the team leadership

• Actively participates in safety walkthroughs coordinated by the department’s safety team

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions including the support of Safety improvement initiatives and investigations.

• Follows effective procedures to ensure the production of a safe and efficacious product.

• Utilizes +QDCI boards for Safety issues

Quality:

• Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections

• Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies

• Supports 5W2H’s and deviation