Charlotte McIlvaine has over 20 years of experience in quality assurance and analytical chemistry roles within the pharmaceutical industry. She has a proven track record of leading quality assurance operations, implementing new quality systems, resolving issues, and ensuring compliance. Her background includes managing QA teams, developing standard operating procedures, performing audits, and overseeing manufacturing and distribution operations. She currently holds the role of Quality Assurance Manager and has transformed QA programs and launched new products at multiple companies.

1. CHARLOTTE MCILVAINE
8510 Elliston Drive | Wyndmoor, Pennsylvania 19038
CharlotteMcIlvaine@yahoo.com | 732.597.8629
QUALITY ASSURANCE (QA) MANAGER
Seasoned QA Manager and Analytical Chemist with deep expertise in the pharmaceutical industry across the entire
product development, manufacturing, and distribution life cycle.
Career success leading implementation, oversight, and alignment of production operations with cGMP, FDA, and
international requirements. Develop and launch high-caliber QA frameworks, including protocols, controls, audit
processes, and standard operating procedures (SOP), liaising across the organization to ensure the highest caliber of
performance across product R&D, regulatory affairs, manufacturing, and release activities. Proven success leading
process and issue analysis efforts resulting in increased quality, productivity, performance, and cost-control.
Core competencies include:
• Quality Assurance & Control (QA/QC)
• Testing, Validation & Transfer Protocols
• New Products & Product Improvements
• Documentation & Reporting Management
• USP, cGLP & cGMP Standards
• Change Controls & Management
• Investigations & Technical Issue Resolution
• Team Building and Training
PROFESSIONAL EXPERIENCE
INSIGHT PHARMACEUTICALS, Trevose, Pennsylvania
Quality Assurance (QA) Manager, 7/2011 to 11/2014
Held responsibility for QA operations spanning 30 domestic and international suppliers, contract laboratory
organizations (CLO), contract manufacturing organizations (CMO), and distribution centers.
Managed quality oversight and led technical review for worldwide operations, overseeing system validation and
product stability programs; directed QA team of 3. Managed new project / product implementations, coordinating
internal and external operational teams, and evaluated CMO deviations, manufacturing investigations, and technical
complaints; liaised and collaborated among supply chain, purchasing, regulatory, operational, marketing, sales, and
auditing / surveillance teams to orchestrate new projects. Managed relations with suppliers, CLO, CMO, and
distribution center partners. Developed technical transfer packages and performed due diligence for product
acquisition, transfer, and divestiture initiatives. Reviewed and approved master packing specifications (MPS).
Produced and reviewed protocols, batch records, installation qualifications (IQ), operational qualifications (OQ),
performance qualifications (PQ), and change controls; approved release of all production. Authored new Quality
Management System protocols, standard operating procedures (SOP), reports, and controls; assisted with MSDS
maintenance and document control. Played instrumental role in departmental budget administration. Attended and
presented QA performance metrics at Quality Management Review meetings; served on CAPA team. Produced
Annual Product Report (APR) for internal / external stakeholders. Spearheaded CMO site inspections to ensure
compliance with FDS and Health Canada regulatory requirements; facilitated third-party audits and inspections.
Key Contributions:
♦ Launched 16 new products and product improvement processes.
♦ Successfully integrated Monistat brand into Quality System, including API and primary packaging changes to
12 NDA product configurations.
♦ Saved $10M+ through seamless transfer of manufacturing for 8 NDA / non-NDA product lines.
♦ Flawlessly transferred analytical technology for 15 test methods from CMOs to CLOs.
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2. CHARLOTTE MCILVAINE — Page 2
♦ Resolved a problematic testing method producing false non-conformance results.
DISCOVERY LABORATORIES, INC., Warrington, Pennsylvania
Team Lead – Raw Materials & Stability / OTL Coordinator, 02/2007 to 07/2011
Led team of 6 Chemists in raw material, stability, and standards testing efforts.
Tested and shipped samples to contract laboratory partners, overseeing chemistry team and assisting with
supervising shipping / receiving operations. Tracked samples and testing time points. Reviewed raw material
specifications and prepared Certificates of Analysis (COA) / Analytical Technical Results Records (ATRRs) for
release of data and materials. Evaluated testing trends, troubleshot lab issues, and investigated deviations; tracked
and analyzed deviation and out-of-specification (OOS) trends. Documented research protocols and produced
stability reports. Audited lab notebooks and reports. Performed project gap analysis to ensure on-time completion.
Ensured compliance with cGMP, Discovery Labs (DSCO) SOP, US Pharmacopeia (USP)-National Formulary
(USP-NF), British Pharmacopoeia (BP), and European Pharmacopoeia (EP) standards.
Key Contributions:
♦ Assisted with standard certification and tracking program, as well as compliance inspections / audits.
♦ Managed analytical methods transfers between DSCO sites and contractors.
♦ Overhauled QC program to achieve FDA compliance; standardized processes, designed stability protocols,
implemented lab equipment and software upgrades, and improved standard operating procedures (SOP).
INTEGRA-LS, Plainsboro, New Jersey
Quality Control (QC) Supervisor, 06/2006 to 02/2007
Oversaw quality control and laboratory operations supporting biomedical device production.
Supervised team of 6 in QC operations, performing review of lab test data and batch records. Developed product
stability protocols and managed stability program. Created and implemented SOPs, validation processes, and
protocols (IQ, OQ, PQ).
Key Contributions:
♦ Revamped QC operations, including sample handling and workflows, to achieve FDA compliance.
♦ Optimized lab staff productivity to achieve production schedules and standardized processes.
KELLY PROFESSIONAL SERVICES, Fort Washington, Pennsylvania…Assigned to McNeil Consumer Healthcare
HPLC Analyst, 07/2005 to 06/2006
Tested pharmaceutical products in alignment with cGMP and USP standards.
Conducted HPLC, GC, UV/VIS, and dissolution testing for diverse products, including solid dosage forms,
injectables, and solutions.
Key Contributions:
♦ Played instrumental role in analyzing pilot plant operations and stability samples; assisted with setting up 2
new lab facilities.
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3. CHARLOTTE MCILVAINE — Page 3
THERICS, Princeton, New Jersey
QA / QC Chemist, 12/2003 to 07/2005
Developed and performed QA/QC procedures for raw materials, components, and products.
Produced QA/QC reports spanning OOS, CAPA, and Non-Conformance Reports to release or reject materials,
components, and products; led development, introduction, and management of quality and ancillary systems.
Created and implemented SOPs, quality standards, testing and validation protocols, and equipment requirements.
Reviewed documentation—Actual Batch Records (ABR), Packaging Batch Records (PBR), and raw material /
component specifications. Maintained electronic documentation suite and quality management / Intranet application
data. Identified and resolved quality issues, leveraging root cause analysis methodologies to diagnose and correct
problems. Supervised entry-level chemists and lab technicians; managed training records.
Key Contributions:
♦ Turned around QC program to achieve FDA compliance and drive product quality; designed standardized
processes, created stability protocols, upgraded lab equipment and software, and overhauled SOPs.
— Designed testing and analytical processes spanning DI water system sampling / monitoring,
conductivity testing sample pulling, microbiological testing, TOC testing, USP physical testing
(specific gravity, viscosity, distillation), and USP limits testing (heavy metals, arsenic).
— Established process, cleaning, test method, and microbial validation protocols.
— Introduced improved product stability protocols.
♦ Spearheaded internal / external audits, including vendor / supplier audits; qualified alternate suppliers.
MINRAD, Bethlehem, Pennsylvania
QC Chemist, 10/2002 to 12/2003
Performed QC testing on raw materials, components, products, and stability samples.
Led team of chemists in QC testing, analysis, and validation efforts; held responsibility for stability program.
Conducted comprehensive review of reports for raw materials, batch records, packaging material / documents, and
COAs for approval and release. Maintained and calibrated lab instruments / equipment; held responsibility for
chemical / equipment purchasing and inventory control.
Key Contributions:
♦ Transformed QC operations to achieve FDA compliance and optimize quality.
♦ Pioneered a cost-effective solution to a plant chloroform issue.
ADDITIONAL EXPERIENCE
Lead Lab Head Analyst, 2001 to 2002 | HOMETEST METS LABS, Waldorf, Maryland
Chemist, 1999 to 2001 | ATLANTIC ANALYTICAL, Whitehouse, New Jersey
Chemist, 1997 to 1999 | VARIOUS COMPANIES FROM NC,VA, AND PA
EDUCATION AND CREDENTIALS
Bachelor of Science in Environmental Science | Minor in Chemistry
FERRUM COLLEGE, Ferrum, Virginia

4. CHARLOTTE MCILVAINE — Page 4
Professional Certification: ASQ-Certified Manager of Quality Operational Excellence, 2014
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