Job Description

Ethicon, Inc., a member of Johnson & Johnson's Companies, is recruiting for a Laboratory Supervisor.

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 help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

The Laboratory Supervisor is responsible for leading and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products and raw materials.

Key Responsibilities:
Managing and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products in order to ensure compliance with quality standards and production schedules with a sense of urgency
Operating in compliance within current GMPs. This includes the ability to understand, write and apply SOPs to meet GMP requirements for documenting, testing and maintaining accurate laboratory records
Working closely with COE and/or R&D in support of development, troubleshooting, validation, instrument qualification and transfer of test methods to a commercial QC laboratory
The use of scientific techniques to provide innovative ways to tackle technical problems and troubleshooting with limited guidance from management or other scientific personnel while maintaining a high level of cGMP awareness
Developing, writing, updating, reviewing & implementing test methods, SOPs, protocols and specifications as the need arises
Technical writing techniques knowledge to perform laboratory investigation and root cause analysis while working with the laboratory resources and/or cross functional teams to successfully resolve audit findings, product non conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design
Supporting Laboratory Instrument/Software Lifecycle Management
Experience on proper use, theory and troubleshooting on the following laboratory instrumentations: UPLC, HPLC, GC, FTIR, pH, KF, Particle counter, RCS
Knowledge on physical analysis ( diameter, tensile strength, visual inspection, theories, practices and methodology to align with current procedures and Pharmacopoeias
Supporting process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.)
Communicating metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality control staff. Evaluates performance and provides opportunities for growth. Communicates department objectives and metrics

Qualifications
Required:
Minimum of Bachelor of Science Degree
6+ years of relevant experience (Postgraduate education applies to years of experience)
Knowledge and proficiency in physical and Analytical testing
Experience working in an FDA regulated environment (21 CFR Part 211 and 211, 21 Part 820, ICH Q7, 21 CFR Part 4, ISO-10993, ISO-11137, ISO-20857, ISO-14644 and ISO-11138)
Good verbal and written communication skills with a good team working ethos
Strong organization skills as a leader on a laboratory environment
Ability to Travel up to 10% domestic and/or international
The Plant is a 24/7 operation; ability to work weekends and holidays as business needs

Preferred:
Technical writing techniques knowledge to perform laboratory investigation and root cause analysis
Knowledge of Microsoft Office, LIMS, and other computer software recommended
Ability to handle multiple items concurrently
Ability to use Laboratory Software Applications such as Chromatographic Data Systems, Laboratory Execution Systems and Laboratory Information Management Systems.
Ability to work independently
Good social, interpersonal and oral and written communication skills
Able to interact well with peers and colleagues
Self-motivated
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.

Primary Location
United States-Texas-San Angelo-3348 Pulliam Street
Organization
Ethicon Inc. (6045)
Job Function
Quality
Requisition ID
2105904702W