Laboratory Supervisor (Supervisor 2, Quality Control) |
Ethicon, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Laboratory Supervisor located in Cornelia, GA or Athens, GA.
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 Supervisor will report directly to the Laboratory Manager and will support manufacturing and timely delivery of product to customers.
•Performs investigations when questionable analytical results have been generated and works in the corrective action implementation.
•Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support the supply chain process.
•The Supervisor is responsible for the day to day management of the quality laboratory.
•The supervisor will assign and direct staff to ensure that product testing is completed in a timely and compliant manner.
•The supervisor is responsible for working with staff to troubleshoot instrument issues, investigate nonconforming data as well as review and issue Certificates of Analysis or Conformance as required.
•Failure to perform his/her functions effectively could result in product recall, production delays and/or back order status.
•Responsible for managing and coordinating 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. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.
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:
•Managing laboratory testing of raw materials, in process materials and finished product in support of the manufacturing schedule and to ensure timely delivery of product to customers.
•Ensuring that all laboratory test methods and procedures are executed in compliance with specifications and standards. Additionally, working in the development, writing, updating and review of test methods, SOPs, protocols, and specifications as required.
•Serving as Subject Matter Expert for testing methodology. Using knowledge of scientific techniques to independently troubleshoot product quality issues of a complex nature with a sense of urgency.
•Ensuring that all laboratory instruments and systems and software are maintained in accordance with procedures and standards.
•Ensuring that all laboratory activities are conducted in accordance with government regulations and safety requirements as well as all Enterprise, Sector and Company policies.
•Reviewing and approving quality records (e.g. non-conformance, CAPA) related to laboratory events.
•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. This will include ensuring that the reports are consistent, complete and in alignment with applicable standards and procedures including appropriate content and references.
•Escalating quality issues to management
•Monitoring laboratory quality data and metrics on a regular basis to ensure that appropriate investigation, corrective action, and/or escalation 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 to meet applicable goals.
•Monitoring data from Contract Laboratories including non-conforming test results. Interfacing with contract laboratory during the laboratory investigation process.
•Leads, develops, trains and coaches lab associates within the laboratory. This includes ensuring that associates have appropriate resources and support to execute testing in accordance with procedures, standards and regulations as well as ensuring that all relevant core competency training modules are completed by the laboratory personnel.
•Maintaining up to date knowledge of the company’s products and manufacturing processes related to relevant laboratory testing.
•Providing audit support (front room, back room and SME).
•Working with cross functional teams to successfully resolve audit findings, product non-conformances, customer complaints, to execute Corrective/Preventive Actions and/or to improve product design.
•Monitoring departmental activities to ensure that laboratory personnel follow all company guidelines related to Health, Safety and Environmental practices.
•Ensuring the timely completion of document reviews and approvals for document changes within their area of responsibility
•Participating in budget planning for the laboratory.
•Responsible to ensure quality agreements have been established with external contract laboratories.
•Responsible to ensure all laboratory equipment is properly qualified, including but not limited to: temperature mapping, calibration and preventative maintenance schedules maintained, etc.
•Responsible for communicating business related issues or opportunities to next management level
•Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
•Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
•Performs other duties assigned as needed
•This position requires bachelor’s Degree, preferably science in Chemistry, Biology or Microbiology.
•Six (6) years of pharmaceutical experience and knowledge in compliance of analytical laboratory systems and minimum 3 years in a supervisor role.
•Have experience in analytical techniques like HPLC, GC, Dissolution, TOC, FTIR, UV-Visible, wet chemistry and microbiology testing.
•Be familiarized with US and International cGMPs and Pharmacopoeia.
•Technical Writing skills.
•Good interpersonal skills, the ability to manage complexity and conflict.
•Strong problem solving and decision-making skills and the ability to influence others regarding quality goals.
•Ability to perform in a leadership role and to effectively manage people
•Good interpersonal, organizational and oral and written communication skills
•Must be able to interact well with peers and colleagues
•Experience in ISO9001, ISO13485 or GMP environment
•Requires ability and flexibility for working hours which includes overtime and weekends as needed
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•High technical knowledge of Chemistry with a broad knowledge in analytical techniques.
•Computer and software skills.
•Technical writing skills.
•Scientific root cause analysis.
•Bilingual (English and Spanish).
•Knowledge of cGMPs and compliance.
•Decision making skills.
•Ability to work in team environment.
ADDITIONAL POSITION REQUIREMENTS
•Work in team environment behaving in a CREDO based respectful manner
•Comply with all federally regulated programs.
•Adhere to J&J environmental and safety policies and guidelines.
•Comply with all job specific safety procedures and utilize PPE when necessary.
•Comply with quality system requirements as defined within procedures and instructions.
•Use test equipment (Starett Gauge, Mitutoyo Gauge, Microscope, etc) where applicable.
•Utilize applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
•Consistently meet required work performance targets (RE’s), if applicable
•Support LEAN and Six Sigma Initiatives.
•Support Maintenance Excellence (ME2) including 6S and Operator Asset Care. Accurately complete records as defined within the job procedures (e.g. manual and/or electronic documentation).
•Perform other work-related duties as assigned by supervisor.
•Consistently meet required Training due date targets
•Experience leading process improvement projects; including but not limited to ownership of change controls, Standard Operating Procedures, and protocols.
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.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
United States-Georgia-Cornelia-655 Ethicon Circle
North America-United States-Georgia-Athens
Ethicon Inc. (6045)