Janssen Supply Group is recruiting for a CRS Quality Control Supervisor position to be located at Malvern, PA!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
The Quality Control CRS Lab Supervisor leads all aspects of day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy and timeliness of specified testing processes inside the Clinical, Release and Stability lab. 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.
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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 mentorship and support throughout the Janssen Supply Chain (JSC) for new initiatives, projects, product transfers and regulatory inspections.
Key Responsibilities:
- Responsible for the efficient and effective functioning of the Quality Control 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 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
- Manage performance of 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
- Support Health Authority inspections
- Review/approve documents as a QC department subject matter expert (SME)
- Ensures laboratory equipment is qualified, maintained and calibrated, as required
- Maintain an orderly laboratory through routine housekeeping
- Provides support for troubleshooting methods and assays
- Review/approve purchase requisitions for laboratory supplies
- Remaining current in skills and industry trends
- Develop business cases for capital projects associated with the QC laboratories
Qualifications
Education:
- Minimum of a Bachelor's degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required
Experience and Skills:
Required:
- Minimum of 4 years of relevant experience in biopharmaceutical or pharmaceutical industry is required. In depth knowledge of analytical test methods (ELISA based assays, PCR, Flow cytometry, Cell count assays, HPLC's, pH, Benzonase, HCP, Residual DNA methods etc.)
- Minimum of 2 years of supervisory experience
- Skilled in basic and advanced analytical methodologies within the functional laboratory is required
- Advanced knowledge/experience with regulatory requirements, policies and guidelines is required
- Significant experience with Quality Control document reviews and regulatory inspection processes is required
- Advanced knowledge of Quality systems is required
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required
- Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is required
Preferred:
- Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.