Brendan Parr
Merrimack,NH
Summary
Quality-focused GMP Chemist with hands-on experience leading CAPA investigations, root cause analysis, deviation management, and compliance initiatives in regulated pharmaceutical manufacturing environments. Proven ability to coordinate cross-functional teams, manage CAPA timelines, support audits, and drive continuous improvement initiatives in accordance with GMP and ICH Q7A guidelines. Experienced with eQMS systems, technical documentation review, effectiveness checks, and maintaining audit-ready operations.
Overview
5
5
years of professional experience
Work History
GMP Lead Chemist
Cambridge Isotope Laboratories, Inc.
Tewksbury, MA
09.2023 - Current
- Lead CAPA investigations and coordinate cross-functional teams to ensure timely completion of corrective and preventive actions in a regulated GMP environment
- Facilitate root cause investigations using 5 Why and Ishikawa methodologies to address deviations, OOS events, and non-conforming products
- Review and revise production records, SOPs, and qualification documentation to support CAPA implementation and regulatory compliance
- Perform detailed GMP documentation reviews to verify accuracy, completeness, and compliance with internal procedures and ICH Q7A guidelines
- Support implementation and effectiveness verification activities for CAPAs related to manufacturing processes and qualified equipment
- Coordinate qualification remediation activities including IQ/OQ/PQ documentation updates following qualification failures
- Maintain audit-ready laboratories and ensure compliance across multiple manufacturing areas and personnel
- Communicate quality and compliance requirements effectively across departments and support training initiatives as needed
GMP Production Chemist
Cambridge Isotope Laboratories, Inc.
Tewksbury, MA
07.2022 - 09.2023
- Manufactured GMP products in accordance with approved procedures and regulatory requirements
- Assisted with deviation investigations, documentation review, and implementation of corrective actions
- Supported writing and revision of GMP documentation including SOPs and production records,
- Worked collaboratively with quality and manufacturing teams to maintain compliance and operational efficiency
Research Assistant
Saint Anselm College
Manchester, NH
05.2021 - 12.2021
- Conducted research on nano-sized surfactant vesicles for targeted drug delivery applications
- Collaborated closely with research leadership and communicated technical findings effectively
- Presented research findings at the annual NH-INBRE Conference in August 2021
Education
Bachelor of Science - Chemistry
Saint Anselm College
Manchester05-2022
Skills
- CAPA Coordination & Implementation
- Root Cause Analysis (5 Why’s, Ishikawa/Fishbone)
- Deviation & OOS Investigation Management
- Corrective & Preventive Actions (CAPA)
- GMP Documentation Review
- EQMS Systems (21 CFR Part 11 Compliant)
- SOP & Production Record Revisions
- Internal Audit Support
- IQ/OQ/PQ Validation & Qualification
- Microsoft Excel & PowerPoint Reporting
- Cross-Functional Team Leadership
- Training & Compliance Support
- ICH Q7A GMP Guidelines for APIs
Timeline
GMP Lead Chemist
Cambridge Isotope Laboratories, Inc.
09.2023 - Current
GMP Production Chemist
Cambridge Isotope Laboratories, Inc.
07.2022 - 09.2023
Research Assistant
Saint Anselm College
05.2021 - 12.2021
Bachelor of Science - Chemistry
Saint Anselm College