Munsimran Sran
Bothell,WA
Summary
Accomplished Quality Assurance professional with a background in supporting the Quality Program within a cGMP regulated facility producing Drug Product/Drug Substance. Previous Quality Control Specialist with experience in supporting production of commerical products.
Overview
8
8
years of professional experience
Work History
Quality Assurance Specialist
Pfizer
Bothell, WA
08.2025 - Current
- Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness.
- Conduct on-the-floor QA review of executed batch records and other manufacturing documentation to ensure adherence to site procedures, regulatory standards and filing requirements.
- Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary.
- Review and approve deviations, including the associated investigation reports, and corrective/preventative actions.
- Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations.
- Review and approve sampling protocols, risk assessments, and master batch records.
- Author, review and approve SOPs as appropriate for both Operations and Quality.
- Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities.
- Participate in internal audits, support regulatory inspections or corporate audit activities, as needed.
Quality Assurance Specialist
Just-Evotec Biologics, Inc.
Redmond, WA
06.2022 - 08.2025
- Review and assess all quality events of eQMS (Deviations, Change Control, CAPA, Risk Assessment, Management Review, Complaint Investigation, Product Quality Review etc.) to assure compliance with regulatory and Just-Evotec Global Quality Management Systems (G-QMS) requirements.
- Provide inputs and reviews on communication as to the status of deliverables to customers, management, and stakeholders.
- Develop, review, and deliver training regarding QMS process or system changes.
- Support QA QMS in internal and external client audits and regulatory inspections (including but not limited to SME for QMS processes and individual records).
- Execute quality batch record review on the Manufacturing floor
- Train and guide alongside the Manager the Quality Assurance team members
- Partner with Manufacturing to ensure compliance on the Manufacturing floor.
- Support product disposition and release of Drug Substance and intermediates
- Implement process performance and product quality monitoring programs
- Alert senior management of significant quality, compliance, supply and safety risk
Quality Assurance Specialist, Quality Assurance
Inventprise
Redmond, WA
04.2021 - 06.2022
- Prepare selected training programs for specific quality systems subjects, such as GMP, data integrity, and good documentation practices.
- Support Safety Training.
- Verify product changeovers (PCOs)/line clearances used to ensure proper cleaning, disinfections, and release of work areas and equipment for subsequent use.
- Review and approve applicable logbooks and test records to ensure complete, timely, and accurate recording of data.
- Apply good documentation practices in all aspects of executing job responsibilities, which include the routine and random review of IVT GMP documentation.
- Support and review data integrity program as needed.
- Ensure proper document archiving and record retention programs are put into place and enforced.
- Support associated investigations and impact assessment when excursions occur.
- At management’s request, conduct internal compliance audits.
Quality Control Specialist, Quality Control
Bio-Rad Laboratories
Woodinville, WA
03.2018 - 04.2021
- QC activities for BioPlex to support production of commercial products
- Evaluate results for validity and acceptability in support of manufacturing for incoming raw materials, in-process materials and finished goods
- Document QC activities using cGMP
- Perform equipment calibrations and maintenance in support of QC Laboratory
- Maintain stock of QC lab supplies and reagents
Education
Bachelor of Arts - Biochemistry
University of Washington
Seattle, WA01-2017
Skills
- Internal/External Audits
- eQMS Systems (Veeva/Compliance Quest)
- Decision-making
- Quality improvements
- Problem-solving skills
- Team collaboration
Timeline
Quality Assurance Specialist
Pfizer
08.2025 - Current
Quality Assurance Specialist
Just-Evotec Biologics, Inc.
06.2022 - 08.2025
Quality Assurance Specialist, Quality Assurance
Inventprise
04.2021 - 06.2022
Quality Control Specialist, Quality Control
Bio-Rad Laboratories
03.2018 - 04.2021
Bachelor of Arts - Biochemistry
University of Washington