Andrew Piper
Fuquay-Varina
Summary
A motivated Quality Manager with 10 years of experience in quality GxP environments, I excel in leading teams to enhance quality processes, ensuring regulatory compliance, and driving continuous improvement. Skilled in analytical problem solving, project management, and audit support, my leadership fosters collaboration and innovation, significantly improving efficiency and effectiveness in quality management.
Overview
10
10
years of professional experience
Work History
Quality Manager
Resilience
03.2022 - Current
- Led, managed, and developed Bioassay team on two shifts.
- Acted as subject matter expert and provided technical expertise as required.
- Authored, reviewed, and approved investigations, deviations, and change controls.
- Ensured compliance with applicable SOPs and cGxP regulations.
- Led and supported CAPA, continuous improvement, and effectiveness check initiatives.
- Partnered with external clients and participated in weekly meetings.
- Interfaced with Quality Control, Quality Assurance, Manufacturing and other cross functional teams as required.
- Managed contract testing laboratories and supported supplier audits.
- Demonstrated knowledge of cGMP/ICH/FDA/Health Canada/EU regulations.
- Organized and performed quality standard training for new and existing staff.
- Improved quality processes for increased efficiency and effectiveness.
- Managed and archived quality documentation and participated in internal and external quality audits.
Senior Associate
Resilience/Bluebird Bio
07.2020 - 03.2022
- Performed analytical testing (H/UPLC, various ELISAs, p/g DNA, wet chemistry, and other cell-based assays).
- Reviewed and evaluated raw data from a peer and technical review level on all analytical methods, as well as sample authorization.
- Authored, reviewed, and/or approved SOPs and technical reports.
- Lead, authored, performed, and reviewed equipment validations.
- Executed phase appropriate test method validation protocols as needed.
- Trained and supported new team members, maintaining culture of collaboration.
- Authored, executed, and/or reviewed critical reagent qualification protocols and reports.
- Authored, executed, and/or reviewed sample control documentation (sample chain of custody, risk assessments).
- Analyzed client data to identify trends and anticipate customer needs.
Quality Control Analyst
Glenmark Pharmaceuticals
11.2018 - 07.2020
- Performed day to day activities for the chemical laboratory including testing of in-process, stability, raw materials, packaging materials, finished product, and cleaning swab samples as applicable.
- Assisted in equipment qualification, calibration, and preventative maintenance as assigned. Equipment includes but not limited to: HPLC, GC, TOC, Malvern, pH meters, density meters, odometers, furnaces, vacuum ovens, titrations, incubators, and biological safety cabinets.
- Executed technology transfers of analytical methods for new products.
- Supported activities regarding audits of suppliers and contract labs.
Chemist II
Ei Solutionworks
04.2017 - 09.2018
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Calibrated and troubleshot all analytical equipment utilized for testing.
- Worked on multiple projects simultaneously and special projects as assigned in a high volume, fast paced environment.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Prepared waste drums for pick-up and delivery to comply with local, state and federal regulations for treatment and disposal of hazardous waste.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
- Established quality control measures for instrumentation and monitored data quality to operate instrument with control limits.
Chemist
Quality Chemical Laboratories
01.2015 - 04.2017
- Performed established quality control test methods such as HPLC, FTIR, moisture content (KF), trimetric assays, UV-Vis, viscosity, and visual appearance.
- Performed method development and method verifications.
- Performed raw material analysis and release testing utilizing USP, EP, JP, BP, ACS, FCC, and other related methodologies.
- Performed technical laboratory functions in compliance with regulatory agencies and safety requirements.
- Recognized and investigated aberrant data with laboratory management.
- Modified and adapted standard methods and procedures to solve analytical problems.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
Education
Bachelor of Science - Marine Biology
University of North Carolina At Wilmington
Wilmington, NC05-2014
Skills
- Quality Management
- Leadership & Training
- Technical & Investigational Writing
- Regulatory compliance
- SOP development
- Internal/External Audit Support
- Mastery of quality processes
- Issue resolution
Timeline
Quality Manager
Resilience
03.2022 - Current
Senior Associate
Resilience/Bluebird Bio
07.2020 - 03.2022
Quality Control Analyst
Glenmark Pharmaceuticals
11.2018 - 07.2020
Chemist II
Ei Solutionworks
04.2017 - 09.2018
Chemist
Quality Chemical Laboratories
01.2015 - 04.2017
Bachelor of Science - Marine Biology
University of North Carolina At Wilmington
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