Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Malvern

Description

Janssen Supply Group, LLC is currently recruiting for a Quality Control Supervisor Car-T. This position will primarily be located in Malvern, PA, with additional oversight of QC employees located in Springhouse, PA

Janssen Supply Group, LLC is a global organization responsible for producing and supplying medicines to markets around the world. With quality as its primary focus, this group collaborates with Research & Development and Commercial partners to deliver life-changing solutions for patients in need.

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. 

The Quality Control Supervisor oversees day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy and timeliness of specified testing processes. The QC Supervisor carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. 

The QC Supervisor typically guides daily work activities of 5 – 15 direct reports within a functional laboratory (biochemistry, microbiology, general chemistry, etc.) of the Quality Control department and reports to the leader of Quality Control for the site.

This position is responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.

This position also provides QC guidance and support throughout the Janssen Supply Chain (JSC) for new initiatives, projects, product transfers and regulatory inspections.

Responsibilities:
• Responsible for the efficient and effective functioning of the Quality Control Car-T lab including the planning, coordination and direct supervision of activities being conducted by Quality Control Scientists.
• Acts as primary contact for manufacturing for testing conducted within the functional laboratory
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Make QC disposition decisions regarding the compliance of batches with established release testing specifications
• Review statistical analysis, data trending, and reporting
• Approve invalid assay and general laboratory investigation records
• Ensure accuracy and completeness of executed analytical method qualification, validation, and transfer activities
• Set testing priorities and manage work assignments
• Train, develop, coach and mentor employees
• Lead recruitment and make hiring decisions for open QC positions
• Manage performance of the laboratory staff and take disciplinary action, where required
• Generates shift schedules, where required, to ensure efficient coverage for all operational needs
• Maintain individual training completion in a compliant state
• Complete corrective and preventative actions (CAPA) as assigned
• Independently execute and manage change control processes
• Lead internal/external audits
• Lead Quality risk assessment teams
• Support Health Authority inspections
• Review/approve documents as a QC department subject matter expert

About the company

If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.

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