Quality Lab Customer Service

CLINT WHEELER

Woodland, CA 925-***-**** ********@*******.***

LABORATORY & FACILITY MANAGEMENT PROFESSIONAL

Experienced People-Leader specializing in organization, communication, team cohesiveness, process improvement, cost-saving initiatives, and urgent or crisis management. Possessing a unique aptitude for getting work teams on the same page. Skilled at leading a team through complex transitions. cGMP Laboratory, Facility, and Calibration/Metrology Management LEAN Fundamentals Proficient Project Management Experienced Facility Operational Management Certified Internal Auditor External Supplier Auditor Develop, Track & Report Metrics/KPI’s Personnel Management: Interviewing, Hiring, Writing & Delivering Yearly Reviews Audit Support: FDA, DEA, ISO, & Clients EXPERIENCE

JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON, Vacaville, CA 2020 - 2022 Sr. Supervisor, Facilities

Lead the site facility (6), Calibration (3) and Metrology (4) maintenance teams servicing manufacturing, warehouse, laboratories and office areas Schedule and assign all routine and non-routine Work Orders Personnel Management: Hiring/Terminations/Performance Reviews Staffing-Level Assessment Budgeting

Audit Support Project Leadership/Implementation

• PM (Preventative Maintenance) and Calibration Work Order execution; installing and removing equipment, critical/urgent equipment repairs; ordering and inventory control for critical spare parts

• Work in conjunction with EHS developing and implementing safety programs

• Partner with engineering and QA to support or lead site improvement projects related to the facility and/or equipment, including PQ and validations

• Utilize performance metrics (KPI’s) to track and improve various aspects of work teams JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON, Vacaville, CA 2004 - 2019 Sr. Supervisor / Supervisor (& Interim QA Laboratory Manager (app. 8 months)), QC Laboratories Management of QC Supervisors Supervision of Analysts/Chemists Personnel Management: Hiring/Terminations/Performance Reviews Staffing-Level Assessment Budgeting Audit Support Project Leadership/Implementation

• Direct and manage approximately 12 scientists (or 5 lab supervisors) in the (cGMP) QC laboratories

(Raw Materials, Finished Products, Microbiology, & Various Support Groups) to support site objective of releasing quality pharmaceutical materials and batches, on time and in full

• Develop, lead, and sustain programs that make safety and quality a top priority and drive the implementation of behavior-based programs

• Provide direction and strategic support to ensure successful launch of new products and new materials. Implement policies and procedures to optimize and maintain lab operations and compliance to align with industry standards

CLINT WHEELER ********@*******.*** PAGE 2

• Set expectations and lead by example for achieving area compliance goals; ensure effective management of NCR’s (i.e., Lab Events/Deviations), CAPA’s, Change Control’s, SOP’s, Equipment & Analytical Method Validation Master Plans, as well as Technical Protocols & Reports

• Own and manage Quality Lab’s financial budgets and headcount projections. Drive to deliver the BP commitments and support the Value Stream (End-to-End) to attain site goals

• Position the lab’s capability to meet and exceed customer service level expectations with Faster Forward continuous improvement and lean belt projects; Empower and coach individuals and teams in agility. Support and encourage Lean belt projects

• Participate as a member of the Site Leadership Team (While Interim manager), Quality Management Team, as well as the JSC One Lab North American & Latin American hub Leadership team

• Supervise test teams and schedule laboratory QC testing according to country specific regulations such as USP, EP and JP compendia as well as internal test methods which ensure country specific compliance

• Oversee all laboratory investigations within respective work groups, including test confirmation criteria, result approval, root cause analyses, and CAPA execution (if applicable)

• Lead internal and external audits including lab tours, back room lab leadership & support and front room interaction with auditors from FDA, EMA as well as other government agencies (Brazil, Japan, Korea, Turkey, etc.)

• Assess and interpret various regulations and remediate gaps through procedural changes and training

• Mentor and formally review associates including managing performance and development plans, writing and delivering end-of-year reviews and ensuring delivery and understanding of compensation information

• Coordinate Method transfers, Method Validations and Capability analysis JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON, Vacaville, CA 1999 - 2004 Assistant Scientist I/II, Raw Materials Laboratory

• Perform QC analyses per EP/USP/JP/ACS and internal test methods. Including but not limited to heavy metals, iron, arsenic, lead, chlorides, nitrates, sulfates. Gravimetric testing (ROI, LOD, ROE, sulfated ash, silica/non-silica, etc.). identification testing (chemical, boiling point, etc.) as well as infrared spectroscopic testing (OMNIC and BIORAD). Physical testing such as Viscosity (Brookfield and Ubbelohde) and Tensile testing of (Thwing-Albert or Instron)

• Conducted routine sampling of all incoming materials such as packaging components, excipients and actives under a GMP environment

• Peer review & approve QC test results

EDUCATION/APPLICATIONS/CERTIFICATIONS

Lean Yellow Belt Certified Certified Internal Auditor Power Point WORD Excel Ariba MAXIMO KRONOS Smart QC TrackWise Compliance Wire WorkDay Docspace eLIMS Microsoft TEAMS Zoom Concur HIGH SCHOOL DIPLOMA Armijo High, Fairfield CA - 1996

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