Analyst Crew Leader

HEATHER COUNTS

*********@*****.*** +1-618-***-**** Kankakee, IL

Quality Systems Professional

SKILLS

● Quality Systems ● Risk Analysis ● Laboratory Techniques

● Project Management ● Process Improvement ● Statistical Analysis

● Writing and Reviewing

MCSRs and APRs

● Defining Root Cause and

implementing CAPAs

● Good Documentation

Practices (GDP)

● 21 CFR Parts 11, 210, 211,

225, 226, 514

● Writing/Reviewing OOx

investigations, Deviations

● Computer System

Validation (CSV)

● Reviewing regulatory

Submissions for NADAs

and VMFs

● Technical Writing (SOPs,

URQs, JHAs, Testing

Methods)

● Trackwise, Veeva Vault,

StarLIMS, Labware LIMS,

SAP, DocNet, Plateau

EDUCATION

Northwestern University Evanston, IL

M.S. in Regulatory Compliance

Concentration in Quality Systems

March 2022 - Present, Anticipated Graduation May 2024 Southern Illinois University Edwardsville Edwardsville, IL B.S. in Biological Science

Minor in Music Education

August 2011 - May 2016

PROFESSIONAL EXPERIENCE

Zoetis Chicago Heights, IL (2021-Present)

Laboratory Supervisor - Quality Control (December 2021-Present)

● Provides oversight of the Quality Control Laboratory including finished product testing, stability testing, raw materials receipt/approval, and process control testing.

● Complete, test, and implement inspection lot builds in SAP.

● Utilizes project management to lead several project teams at once.

● Utilizes process improvement methodologies like DMAIC and 5S to create lean processes

● Hire, mentor and develop talent within the QC Laboratory CSL Behring Kankakee, IL (2018-2021)

QC Team Lead - Chemistry In-Process (January 2020 - December 2021)

● Led a team of 15 QC Analysts in the Chemistry In-Process laboratory, a 24/7 support group

● Created schedules, conducted meetings with analysts, helped with analyst development

● Provided support during internal and external regulatory inspections of the facility; worked in back room during FDA inspection to fulfill incoming requests

● Enforced safety within the lab, led by example and ensured everyone was compliant

● Tracked analyst training by pulling reports from SAP SuccessFactors - Plateau to ensure everyone was properly trained prior to performing the job

● Attended in house Supervisor Essentials Training as well as in house Self Leadership Training

● Performed testing and review of samples and all additional responsibilities listed under previous titles of QC Analyst II and QC Analyst I

QC Analyst II - Chemistry In-Process (November 2019 - January 2020)

● Became qualified trainer and started training incoming personnel

● Completed Maintenance, Calibration and LPQ requirements for instrumentation including but not limited to: LECO Nitrogen Analyzers, Gas Chromatographs, Spectrophotometers, Versamax Microplate readers, pH Meters, pipettes and dispensers

● Performed testing/review of samples and all additional responsibilities listed under previous title of QC Analyst I

QC Analyst I - Chemistry In-Process (September 2018 - November 2019)

● Tested In-Process Materials per SOPs upon submission to the lab

● Reviewed data produced by other analysts and released results

● Followed the 5S Plus organization methodology to improve various areas of the lab

● Attended off-site training for LECO Nitrogen Analyzer at LECO in St. Joseph, MI

● Followed all cGMP and Safety guidelines

CSL Plasma Knoxville, TN (2016-2018)

Laboratory Assistant II (August 2016 - September 2018)

● Worked in a high throughput viral testing laboratory, assisting Medical Technologists with the testing of donated plasma by PCR.

● Operated and maintained automated laboratory equipment

● Controlled sample inventory using StarLIMS

● Reported deviations to supervisor and assisted in investigating root cause Office Max Wood River, IL; Glen Carbon, IL; and Knoxville, TN Print Specialist (March 2015 - August 2016)

● Produced custom graphic designs and printed products for customers

● Gained customer loyalty by producing quality designs and delivering final product efficiently Subway Restaurants Edwardsville, IL

Crew Leader (March 2013 - May 2015)

● Led a team of approximately 6 crew members and provided service to customers

Contact this candidate