Quality Assurance Hr Manager

Jeff Stapley

Farmington, UT ***** 307-***-**** ********@*******.*** www.linkedin.com/in/jestapley

PRINCIPAL ANALYTICAL SCIENTIST

PHARMACEUTICALS CONSUMER PACKAGED GOODS

Highly-experienced scientist/manager with a proven track record of improving scheduling, planning, and budgeting. Excellent scientific skills, obtained through extensive product development and laboratory experience. Deep knowledge of cGMPs, including extensive, successful participation in FDA, USDA, MHRA, EMEA, Health Canada, EPA, DEA, OSHA, NSF, Kosher, Halal, GMA-Safe, ISO-9001:2015, and BRC/GFSI audits.

CORE COMPETENCIES

People Management Quality Assurance/Control Management/Annual Product Review Auditing

Budgeting Strategic Planning Equipment/Process/Method/Computer/Cleaning Validation CAPA HACCP

PROFESSIONAL EXPERIENCE

TEVA PHARMACEUTICALS, Salt Lake City, UT 2021 - 2024

Global pharmaceutical company producing generic drugs, active pharmaceutical ingredients, and branded drug products.

Principal Analytical Scientist

Oversaw method development and validation for analytical test methods.

Wrote validation reports and test methods.

Served as controlled substance coordinator with database access for the Analytical Research and Development group.

Performed mid-year and annual controlled substance inventories.

Served as Department Glorya Coordinator.

Used Trackwise Harmony for writing and reviewing deviations.

Ran and performed routine maintenance on a wide variety of laboratory equipment, which included HPLC/UPLC with PDA/MS Detectors, and GC FID/MS.

Assisted the Director with DMF and CRL reviews.

CHURCH & DWIGHT CO., INC., Green River, WY 2010 - 2021

Consumer packaged goods company producing Arm & Hammer products in Wyoming.

Quality Assurance Quality Control Supervisor

Oversaw total plant quality (5-6 employees), including batch release, scheduling, quality auditing, supplier auditing, SOP writing, and training, and developed the GMP program.

Interacted with regulatory agencies (FDA, NSF, Kosher, Halal, BRC, GMA-Safe, GFSI), maintained certifications (ISO-9001:2015, NSF, Kosher, Halal, GMA-Safe, GFSI), and oversaw certification from BRC for GFSI. No 483 or equivalent observations.

Introduced new SOP system with consistent numbering and formatting as well as updating old content to match current processes.

Validated the control software that ran the baking soda and laundry detergent plants including the User Requirement Specification, Functional Specification, Design Specification, Configuring, IOPQ and Final Report. Also validated the manufacturing lines for baking soda.

Charged with the Management Review, Annual Product Review, Quality Investigations, Validations, Document Review and Approval, CAPA, Stability, and HACCP. Met all compliance goals for all registrations and certifications.

Developed site HACCP plan with Food Safety Specialist, including the risk assessments.

Used various software, including SAP, Minitab, WMS, Trackwise and Microsoft Office Suite.

ADDITIONAL RELEVANT EXPERIENCE

WATSON LABORATORIES, INC., Salt Lake City, UT, Manager, Laboratory Technical Services, Quality Control 1992 - 2010

Supervisor, Stability, Quality Control

Supervisor Analytical Research & Development

Scientist III Supervisor, Scientist II Supervisor Analytical Research & Development

Scientist I Analytical Research and Development

Scientist I Transdermal Research

COMMERCIAL TESTING AND ENGINEERING, Huntington, UT, Chemist

EVANS AND SUTHERLAND COMPUTER CORPORATION, Salt Lake City, UT, Certified Surface Mount Operator / Supervisor

Jeff Stapley ********@*******.*** Page 2

EDUCATION

Bachelor of Science (BS) in Chemistry

UNIVERSITY OF UTAH, Salt Lake City, UT

MEMBERSHIP AFFILIATIONS

American Chemical Society, Washington, DC

American Society for Quality, Milwaukee, WI

PROFESSIONAL DEVELOPMENT

5 different supervisory or project management courses including ASQ Certified Manager of Quality in Operational Excellence and ISO Lead Quality Auditor

4 courses related to statistical analysis, including JMP software and ACS Statistical Analysis of Laboratory Data

5 instrument specific and chromatography courses

3 stability and GLP/ISO-9000 courses

2 software specific courses

*Courses were taken from various professional organizations, instrument vendors and on-site training professionals.

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