Description

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to helping address the world's most pressing healthcare issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treating serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .

JOB SUMMARY

Responsible for conducting complex test and analysis to assure that product comply with established specifications.

DUTIES & RESPONSIBILITIES

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Performs raw material, in-process and/or finished goods tests and reviews.

• Able to work in an environment with chemicals safely.

• Inspects, tests and/or evaluates the precision and accuracy of products, and/or testing equipment.

• Monitors and reviews environmental charts and/or numeric data.

• Performs chemical and sterility release of product.

• Performs sterility, environmental, moisture, residual ethylene oxide, and triclosan testing.

• Carries out difficult calculations and prepares documentation that shows the results for the test performed.

• Prepares media and performs quality assurance control checks per USP.

• Investigate and write out of specification reports.o Read and interpret results, performs trend analysis as required.

• Recommends, amends and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.

• Performs other duties assigned as by any member of Laboratory Management.

• Execute simple microbiology analyses in-process sample and finish products (Microbial count, Environmental Monitoring and sterility test) to comply with current procedures and Pharmacopoeias.

• Basic knowledge on microbiology principles, theories, practices and methodology.

• Basic Technical writing techniques knowledge to perform preliminary laboratory investigation.

• Completes record of inspection results, acceptance, rejection and disposition for entry into logbooks or computer systems (i.e. LIMS).

• Support process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)

• Responsible to ensure adequate systematic control of nonconforming product.

• Recommends and implements revisions, corrections and changes to test equipment, procedures and methods.

• Experience on proper use and basic troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS.

• Participates on special requests for product testing, such as qualification protocols

• Initiates and coordinates discussions with quality, engineering and other relevant departments to develop corrective actions for reoccurring problems

• Conducts training for lower level technicians and operations.

• Cross-trains to support other functional areas.

• Ensures proper safety and environmental procedures and practices are utilized

• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001)

Qualifications

• University / Bachelor’s Degree or Equivalent is required with major on Science preferred

• Generally Requires 0-2 Years Work Experience

• Good interpersonal relations and communication skills required

• Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended

• Demonstrated knowledge and expertise in quality processes and regulatory requirements.

• Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7 and/or 21 CFR Part 4)

• Basic Spectroscopy knowledge (theorical and practical) to evaluate and troubleshoot chromatography analysis, document and review chromatography and/or spectroscopy (GC, UPLC, HPLC, FTIR, etc.) results that could impact the results for the test performed.

• Basic wet chemistry techniques related to qualitative and quantitative

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 .