Summary
Overview
Work History
Education
Skills
Software
Timeline
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Analisa Molewicz

Nashua,NH

Summary

Experienced Quality Assurance professional with 9+ years of GMP experience within pharmaceutical and biotech industries, specializing in batch release, disposition, and quality systems management. Proven ability to reduce backlogs, ensuring compliance with global standards, and streamlining QA processes. Skilled at thriving in high-volume, deadline-driven environments, with strong analytical abilities and attention to detail, ensuring reliable and consistent quality outcomes. Adept at mentoring teams and fostering continuous improvement. Seeking to leverage expertise in disposition and global quality oversight to drive product excellence and regulatory compliance

Overview

9
9
years of professional experience

Work History

Senior Quality Assurance Specialist

ModernaTX, Inc.
10.2022 - 08.2025
  • Led batch release and disposition of GMP drug substance, drug product, and critical raw materials, serving as the quality point-of-contact for release readiness and issue resolution, and accelerating timelines and reducing compliance risk through product quality assessment, deviation evaluation, and cross-functional collaboration.
  • Reduced regulatory backlog by 35% and external change closure backlog by 48%, contributing to a 32% total backlog reduction globally through strategic prioritization and continuous improvement initiatives.
  • Oversaw on-time closure of all regulatory-impacting change controls across the external network, partnering with Regulatory Affairs to ensure country-specific filing alignment and timely compliance.
  • Managed 115+ external/CMO-related Quality Events, including deviations, CAPAs, process changes, CMO-driven updates, and new product introductions, ensuring compliance with contractual and regulatory requirements.
  • Provided QA oversight of quality systems supporting upstream and downstream activities at Contract Manufacturing Organizations (CMOs), ensuring adherence to internal quality requirements, regulatory standards, and contractual agreements.
  • Served as QA SME for system upgrades and remediation efforts, including SAP, SAP MDG, Smartsheet, and Veeva, while driving continuous improvement projects to enhance quality systems and data integrity.
  • Generated and analyzed quality metrics to monitor site health and inform management reviews, supporting data-driven decision-making.
  • Mentored junior team members, fostering a culture of continuous learning and improvement within the QA department.

Quality Assurance Specialist

ModernaTx, Inc.
06.2021 - 10.2022
  • Reviewed and approved CGMP batch records, technical documents, SOPs, and material specifications to ensure compliance and product quality.
  • Performed final product disposition and supported incoming material release by verifying adherence to specification requirements.
  • Provided floor-level QA leadership during critical manufacturing, including supervising suite changeovers and escalating quality-impacting events.
  • Reviewed and approved manufacturing related quality events including deviations, CAPAs and both process and document-related change controls.
  • Ensured proper record handling and product impact justifications to facilitate on-time drug product release.

Quality Assurance Specialist

SOFIE Biosciences
04.2019 - 06.2021
  • Directed site-level QMS and QA programs supporting GMP compliance under 21 CFR Parts 211 & 212, ensuring operational readiness and compliance for radiopharmaceutical manufacturing.
  • Executed quality oversight of manufacturing operations; led batch record reviews, QC data evaluation, and final product disposition to maintain quality standards.
  • Spearheaded investigation of an adverse mold trend within ISO-classified cleanrooms; coordinated cross-functional remediation to restore environmental controls and ensure GMP compliance.
  • Authored risk assessments supporting critical quality decisions to protect product integrity and patient safety.
  • Eliminated 5-year QMS backlog, achieving 100% closure of overdue records, improving inspection readiness.
  • Mentored junior QA specialist and led successful FDA, BOP, NRC, EHS, and external partner audits.

QC Production Technician /Certified Pharmacy Technician

SOFIE Biosciences
06.2016 - 04.2019
  • Supported GMP production and quality control of radiopharmaceuticals under 21 CFR 211 and 212 in a sterile manufacturing environment.
  • Performed GMP analytical testing (GC, HPLC, MCA, TLC) and reviewed results for release of daily radiopharmaceutical batches, ensuring compliance with predefined specifications.
  • Trained new team members on equipment operation, safety protocols, and company policies, fostering a skilled workforce.
  • Ensured adherence to ALARA principles while working with radioactive materials and upheld all site safety protocols.

Education

Bachelor of Science - Pharmaceutical Sciences

MCPHS University
Boston, MA
05-2016

Skills

  • Batch Disposition
  • Material Release
  • GxP knowledge
  • Industry based knowledge
  • Detail-Oriented Documentation Review
  • Continuous Quality improvement
  • Process optimization
  • Compliance Management
  • Project Execution and Tracking
  • Adaptability and flexibility

Software

VeevaeQMS

SAP

Veeva RIM

Labvantage LIMS

Infobatch

VeevaQualityDocs

Veeva Batch Release

Adobe

Docusign

Smartsheet

Timeline

Senior Quality Assurance Specialist

ModernaTX, Inc.
10.2022 - 08.2025

Quality Assurance Specialist

ModernaTx, Inc.
06.2021 - 10.2022

Quality Assurance Specialist

SOFIE Biosciences
04.2019 - 06.2021

QC Production Technician /Certified Pharmacy Technician

SOFIE Biosciences
06.2016 - 04.2019

Bachelor of Science - Pharmaceutical Sciences

MCPHS University

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