Darlene Pierson
Quality Assurance Professional - GXP, Validation, CSV, Auditing, Leadership
- Role
- Sr Manager Qa at ZigZag QA
- Location
- Greensboro, NC, US
- LinkedIn followers
- 500 followers
About Darlene Pierson
Comprehensive regulation and guidance knowledge: cGxPs, ISO17025, ISO9001, ISO13485, FDA regulations 21CFR Title 21 regarding medical devices and drugs. ICH/135/1995, EU Annex 13, EU Annex 11, GAMP 5, EU 2017/556, ICH Q9. Excellent Internal & External auditing skills. Experience collaborating with outside suppliers (components, chemicals, software, and equipment) including audit, capability assessment, and quality alignment. Validation SME including VMP, Risk Assessments, User Requirements, Design Specification, Test Plans, FAT/SAT/Commissioning, DQ, IQ, OQ, PQ, QC Testing Equipment, Cleanroom Qualification, Environmental Control, Cleaning, Process, and Facilities. Computer System Validation (CSV) proficiency for legacy systems and new systems including lifecycle plans, validation plans, data migration, disaster recovery and summary reports according to FDA 21 CFR Part 11, 211, 820; EudraLex Annex 11, and guidance (e.g, FDA, GPSV, ICH, PIC/S), and industry best practices (e.g, ISPE, GAMP 5) Strong Technical Writing skills, authoring of SOPs, policies, justifications, summary reports, risk assessments, quality plans, quality manual, validation documentation, specifications, and methods. Comprehensive Quality Management System understanding of CAPAs, Non-Conformances, Audit Responses, investigations, change controls and SCARS using risk-based processes. Experienced in pilot plant through scale-up to a GxP manufacturing and distribution facilities, and expansion of existing GxP sites, including the installation and ISO17025 certification of a Metrology Lab. Managed teams where personnel were valued, trained, and mentored while tracking KPIs, maintaining budgets, performing strategic, and developing process improvement projects. Safety Committee member and safety advocate. Extremely successful working directly with clients regarding conducting audits, QTA development, CSV topics, validation (CSV. facility and equipment) and issue remediation.
Experience
Sr Manager Qa
Sep 2024 — Present
Provide a variety of Quality Assurance (QA) services to external clients and to conduct contracted activities in accordance with contractual requirements, regulations, guidelines and Standard Operating Procedures (SOPs).
Education
County College of Morris
Associate of Science (A.S.), Biology, General
1995 — 1997
County College of Morris
Associate of Science; Associate of Science, Biology; Medical Lab Technology
1995 — 1997
William Paterson University of New Jersey
Bachelor's degree, Biotechnology
1997 — 2002
Skills
- Computer System Validation
- Manufacturing
- Pharmaceutical Industry
- Biotechnology
- Instrument Validation
- Quality System
- Document Management
- Test Validation
- Cleaning Validation
- Capa
- Environmental Monitoring
- Trackwise
- Hplc
- Quality Assurance
- 21 Cfr Part 11
- Change Control
- Aseptic Processing
- Technology Transfer
- Software Documentation
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