Laboratory Supervisor - Johnson and Johnson

Ethicon Inc. a member of Johnson & Johnson Family of Companies is recruiting for a Laboratory Supervisor to join our outstanding team, located in Cornelia, GA!

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/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to build a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to tackle the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Supervisor will report directly to the Laboratory Manager and will support manufacturing and timely delivery of product to customers. This is a high visibility role pertaining to direct oversight of Outbound testing requiring high engagement with partners. The role provides opportunity for complexity management through direct supervision of Lab areas with varying degree of complexity. In addition to managing and coordination day-to-day activities this role ensures adherence to regulatory, Health, Safety and Environmental requirements.
Key Responsibilities:

• Leading laboratory testing of raw materials, in process materials and finished product in support of the manufacturing schedule and to ensure timely customer delivery and participating in Budget planning.
• Serving as Subject Matter Authority for testing methodology. Using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature timely.
• Driving the investigation of non-conforming laboratory test results as well as reviewing and approving laboratory OOS and OOT events including related quality records and investigation reports.
• Responsible to ensure all laboratory equipment and Test Method are qualified, as well as Ensuring instruments and systems and software are maintained in alignment to Lifecycle Management Requirements.
• Providing audit support (front room, back room and SME). Resolve audit findings, product non-conformances, customer complaints, and implement Corrective/Preventive Actions and/or to improve product design.
• Ensuring that all laboratory test methods and procedures are implemented in compliance with specifications and standards. Additionally, working in the development, writing, updating and review of test methods, SOPs, protocols, and specifications as required.
• Supervising laboratory quality data and metrics on a regular basis to ensure appropriate investigation, corrective action, and/or customer concern is conducted as required for recurring trends involving products, methodologies, instrumentation and scientists. This includes taking appropriate action to drive timely resolution of laboratory nonconformances and CAPA in line with due diligence expectation.
• Leads, develops, trains and coaches Laboratory Team Leads and other Laboratory associates. Including prioritization and Focus on proficiency modules.

Education:

• Minimum of a Bachelor's degree or University equivalent in Chemistry or related Scientific field is required.

Experience and Skills:

Required:

• A minimum six (6) years of related work experience in Medical Device, Pharmaceutical or similar regulated industry.
• Experience and broad knowledge in analytical techniques and compliance of analytical laboratory systems.
• Experience performing in a Leadership role and effectively leading people.
• Experience with Root Cause Analysis methodologies and Technical Writing.
• Experience with Laboratory Scheduling and Performance Measurement.
• Strong problem solving and decision-making skills and the ability to influence others regarding quality goals.
• Experience leading Scientists and Technicians (various Levels).

Preferred:

• Interaction with representatives from Notified Bodies for auditing as well as representatives from FDA.
• Certifications in LEAN and or Six Sigma, Leadership and Scientific/Authority Associations.
• Familiarity with US and International cGMPs and Pharmacopoeia.
• Test Method Validation and Transfer.

Other:

• This position will be located in Cornelia, GA and may require up to 10% domestic or international travel.
• Occasional onsite support at our Athens, GA location.

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 .