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Laboratory Supervisor

Key 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
Qualifications
Education:
Bachelor s of Science degree in Chemistry required
Experiences & Skills:
Minimum 6 years of pharmaceutical or FDA regulated experience required
Knowledge in compliance of analytical laboratory systems required
Experience with analytical techniques like HPLC, GC, Dissolution, TOC, FTIR, UV-Visible, wet chemistry required
Familiarly with US and International cGMPs and Pharmacopoeia required
High technical knowledge of Chemistry with a broad knowledge in analytical techniques required
Experience with Non-Conformance Investigations (NCI) and CAPA s required
Scientific root cause analysis required
Knowledge of cGMPs and compliance required
Technical Writing skills required
Bilingual (English and Spanish) preferred
Previous people management experience preferred
Resource and performance management experience preferred
LEAN or Six Sigma certifications preferred
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 targetsOther:
Up to 10% domestic/international travel required
Ability to support the Athens, GA site as needed required
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.
Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.


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