Ethicon, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Laboratory Supervisor. This position is in San Angelo, TX and is eligible for relocation assistance.
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 commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.
The QC Microbiology Supervisor is responsible of leading the activities of the Quality Control associates engaged in sorting, testing, and inspecting Microbiological samples related to environmental and utilities process. The Laboratory Supervisor is also responsible for 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.
- Responsible for managing the activities of the Quality Control associates engaged in sorting, testing, and inspecting products and raw materials in order to ensure compliance with quality standards and production schedules with a sense of urgency.
- Work 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.
- Use of scientific techniques to provide innovative approaches to solve technical problems and troubleshooting with limited guidance from management or other scientific personnel while maintaining a high level of cGMP awareness.
- Develop, write, update, review & implement test methods, SOPs, protocols and specifications as required.
- 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.
- Support Laboratory Instrument/Software Lifecycle Management.
- Knowledge on microbiological principles, theories, practices and methodology to align with current procedures and Pharmacopoeias.
- Support Chem laboratory associate and process improvement teams for departmental and company continuous improvement activities (Lean, compliance laboratory processes, etc.).
- Support the microbiology team on basic microbiology principles and methodology
- Communicates 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.
- A minimum of a Bachelor’s Degree is required. A Bachelor’s Degree in Microbiology or equivalent is preferred.
- A minimum of six (6) years of work experience required and a minimum of five (5) years of microbiology or related experience required.
- A minimum of two (2) years of supervisor experience required.
- Strong organization skills as a leader on a laboratory environment required.
- 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) required
- Good verbal and written communication skills with a good team working ethos required
- Strong organization skills as a leader on a laboratory environment required
- Knowledge of technical writing techniques to perform laboratory investigation and root cause analysis preferred.
- Knowledge of Microsoft Office, LIMS, Empower and other computer software recommended.
- Basic knowledge on Chemical analysis preferred.
- Knowledge of/experience with Medical Device sterilization processes preferred.
- Less than 5% domestic and/or international travel may be required.
- The San Angelo Plant is a 24/7 operation; weekends and holidays are included in the work schedule.
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.
United States-Texas-San Angelo-
Ethicon Inc. (6045)