Senior Supervisor QC
Janssen Biotech, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Supervisor, Quality Control - Release testing . This position will be based in Malvern, Pennsylvania.
Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? Apply today!
The Senior Supervisor, Quality Control Release testing leads all aspects of day-to-day Quality Control activities for the team, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. The Senior Supervisor, Quality Control Release testing 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.
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. Oversees the Release testing team supporting raw material and final product testing, including bioassay, separation and tissue culture assays.
- Responsible for the efficient and effective functioning of the Quality Control microbiology team including the planning, coordination and direct supervision of activities being conducted by Quality Control Scientists.
- Acts as primary contact for manufacturing for services conducted within the organization.
- 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 performed analytical method qualification, validation, and transfer activities
- Set priorities and manage work assignments
- Train, develop, coach and mentor employees
- Manage performance of staff and take disciplinary action, where required
- Generates schedules 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 complete 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
- Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, Chemistry, or related field is preferred.
- Minimum of 6 years of relevant experience in medical device, biopharmaceutical, or pharmaceutical industry
- Skilled in basic and advanced analytical methodologies within the functional laboratory
- Advanced knowledge/experience with regulatory requirements, policies, and guidelines
- Significant experience with Quality Control document reviews and regulatory inspection processes
- Advanced knowledge of Quality systems
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
- Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing
- Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
- Prior leadership experience, microbiology project management accepted
- Detailed knowledge and experience in applying statistical concepts to laboratory data
- Experience in leading direct reports
- Ability to travel up to 10% domestic and international travel
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.