CSL Behring
  • Americas, US-PA, King of Prussia
Aug 07, 2022  
1 Responsible for maintaining quality oversight of implementation activities including but not limited to execution of implementation checklist action items, equipment management, supply management, document management and training. Troubleshooting implementation exceptions and making necessary adjustments to ensure an efficient and effective project implementation in plasma centers. 2  Provide quality compliance oversight of deployment team members and plasma centers involved in the implementation. Identify and manage issues of non-conformity including implementing containment and remedial actions, implementing corrective actions, ensuring appropriate documentation of non-conformance and determining effectiveness of these actions. Responsible for notification to the Assistant Manager of Quality Assurance, Innovation or Associate Director Operations and Quality, Innovation for any event that negatively affects the safety, quality, identity, purity or potency of the product that...
CSL Behring Remote, FL, United States
Aug 07, 2022  
CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that same promise to save and improve lives.  We offer the broadest range of quality plasma-derived and recombinant therapies in our industry.  We have recently been awarded America’s Best Employer for 2022 by Forbes magazine thus offer an exciting opportunity to join CSL as Quality Systems Manager- Change Control Quality Systems Manager – Change Control This role is responsible for: Site Change Control Process/Quality System owner to ensure compliance with CSL standards and Regulatory guidelines. Manages the following aspects of site change control: Establishes and maintains training Site SOPs and work instructions in relation to Change Control Accountability for Regulatory Inspection, Self-inspection, system improvements, and deviations for the Change Control Quality System. This position reports to:  Sr. QA Compliance Manager Principal Responsibilities: Local system...
CSL Behring Kankakee, IL, United States
Aug 07, 2022  
You will report to the Director Associate, Operations and Quality. Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system. Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of KPIs, cause and failure mode impact assessment and change management. You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company policies/procedures. Follow all HR practices through fair treatment of all employees. Monitor CAPA's and effectiveness checks to ensure issues are resolved. Overnight travel required up to 10% of the time. Education Bachelor degree in scientific...
CSL Behring Loiza, PR, United States
Aug 07, 2022  
You will report to the Director Associate, Operations and Quality. Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system. Manage the Quality Control program, calibrations management, monitor of compliance to defined processes e.g. sampling, competency checks, trending and analysis of KPIs, cause and failure mode impact assessment and change management. You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state and local regulatory, company policies/procedures. Follow all HR practices through fair treatment of all employees. Monitor CAPA's and effectiveness checks to ensure issues are resolved. Overnight travel required up to 10% of the time. Education Bachelor degree in scientific...
CSL Behring Ponce, PR, United States
Aug 07, 2022  
Responsibilities: • Controls production activities, material flow, and inventory to achieve cost and quality targets and production schedules of assigned production line(s) • Supervises activities of production operators to assure safe, efficient manufacture of quality products in accordance with policy and procedures • Coordinates with Maintenance, Engineering, Quality Control and Quality Assurance to assure and improve cGMP compliance • Manages daily scheduling of employees to ensure lines are staffed with appropriate manpower • Monitors, reviews and completes manufacturing procedures and log books • Ensures that manufacturing area and equipment are in satisfactory condition • Oversees continuous improvement activities and visual control boards Qualifications: • Bachelor degree or equivalent, or equivalent vocational or technical education • Expert knowledge of cGMP requirements required • 3-5 years' production experience • 0-2 years' managerial experience Different...
CSL Behring Kankakee, IL, United States
Aug 07, 2022  
The Opportunity Provide leadership and direction to assure compliance with all regulatory requirements while managing cost, collections, safety and organizational objectives. In this role, you will report to the Sr. Director Quality Assurance. The Role Responsible for ensuring centers within the region are operating in compliance with FDA, GHA, OSHA, cGMP and other regulatory authorities Ensures a safe working environment for all employees and customers, while driving quality, operational and safety excellence Directs the implementation and management of strategies and activities to support company objectives across region Execute Quality plans for the CSL plasma organization and leads large, complex project initiatives that may have both local and global impact. Direct Formal FMEA and serve as the Subject Matter Experts in the facilitation of formal risk assessments, investigations and determine downs stream impact and need for escalation Responsible for at least...
CSL Behring Remote, FL, United States
Aug 07, 2022  
CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry.  We have recently been awarded   America’s Best Employer for 2022 by   Forbes  M agazine thus offering this excellent opportunity to join CSL as Sr. Quality Compliance Manager. The Senior Quality Compliance Manager  will report to the Head of Site Quality This role is responsible for: Executing changes within the Value Streams, from beginning to end, collaborating with a network of Subject Matter Experts, to ensure the cGMP documentation exists to support the change, and follows the quality system. This role will partner closely with the Quality Delegate in the Value Stream to build robust changes, identifying impacted areas to assess the change. Responsibilities: Responsible for developing and implementing Quality...
CSL Behring Kankakee, IL, United States
Aug 07, 2022  
Position Purpose:  The Process Owner will collaborate with Manufacturing, Quality, and Facilities & Engineering to ensure it continues to meet internal customer, business, and patient needs. The primary aim of the role is to lead key process transformation, design and improvement efforts. The Process Owner will lead a mix of strategic and tactical assignments of various complexities each with an opportunity to achieve measurable results. The incumbent will exhibit knowledge and provide coaching/training to colleagues while leading process and quality initiatives, as necessary. Main Responsibilities and Accountabilities:    Demonstrated ability to understand what is critical about the process.  Recognizes what are the critical quality attributes and process parameters.   Understands what about the output is important to internal customers of the process. Ability to identify what about the process is tied to the regulatory filings.   Monitors process performance with...
CSL Behring Kankakee, IL, United States
Aug 07, 2022  
This position is responsible to lead operational excellence and data analytics initiatives on the Kankakee site, and manage cross functional teams to ensure projects are rolled out and delivered according to milestones, budget and other relevant factors (eg. cGMP, Safety-, Reliability- (service-, costs-, capital-) aspects). Main Responsibilities and Accountabilities: Ensure all aspects in projects are conducted in a safe manner and meet all site and company EHSS policies.                               Ensure the cascade of the network strategy onto the Kankakee site and to link it with the Kankakee roadmap for OE and DA, in close collaboration with the Site Operations Leadership team and the Project Portfolio Team Lead operational excellence and data analytics initiatives on site level, being the owner of the corresponding methodologies, monitoring and managing the progress of the OE/DA roadmap Ensure that scope, milestones/deadlines and activities are met...
CSL Behring Kankakee, IL, United States