Amber M

Quality and Technical Documentation professional with 9+ years of experience in pharmaceutical, biotechnology, medical device, and manufacturing environments. Expertise in GMP compliance, quality systems, deviation investigations, CAPA management, technical writing, batch record review, process improvement, and cross-functional collaboration. Proven ability to drive quality improvements, support regulatory audits, investigate complex manufacturing issues, and ensure compliance with FDA and industry standards.

Technical Writer - Catalent Pharma Solutions

(2025-04 - 2026-06)

• Authored and revised Master Batch Records, protocols, and technical documentation supporting manufacturing and packaging operations.
• Collaborated with SMEs to ensure documentation accuracy, compliance, and operational effectiveness.
• Supported FDA and client audits through timely retrieval and review of controlled documentation.
• Maintained MRP data and support process improvement initiatives.

Sr. Quality Records Specialist - Thermo Fisher Scientific

(2024-01 - 2025-12)

• Reviewed GMP manufacturing records for accuracy, completeness, and regulatory compliance.
• Resolved documentation discrepancies and identified process improvement opportunities.

Quality Engineer - ABB

(2024-01 - 2024-12)

• Supported manufacturing and supplier quality initiatives and drove quality metric improvements.
• Participated in investigations, corrective actions, and continuous improvement programs.

Quality Assurance Associate II - Purilum

(2023-01 - 2023-12)

• Supported deviations, change controls, customer complaints, and batch disposition activities.

Project Engineer - Flagstone Foods

(2022-01 - 2023-12)

• Led engineering project activities, equipment implementation, validation, and capital project support.

Associate Quality Engineer - Moen

(2022-01 - 2022-12)

• Supported supplier quality, PPAP documentation, audits, and customer complaint investigations.

Quality Engineer – Operations / Manufacturing Support Specialist - Pfizer

(2019-01 - 2021-12)

• Conducted investigations, risk assessments, CAPAs, and quality assurance reporting.
• Certified Pfizer Human Performance (PHP) Practitioner.

Environmental Monitoring Analyst - Pfizer

(2017-01 - 2019-12)

• Performed environmental monitoring analyses and reported results through LIMS systems.

Data Review Auditor - Fresenius Kabi

(2016-01 - 2017-12)

• Reviewed laboratory and environmental monitoring data for GMP compliance and quality investigations.

Bachelor of Science - Biology - University of North Carolina at Pembroke (2014)

Pharmaceutical Services Network Oral Solid Doses Manufacturing - Pitt Community College (2026)