Work Preference
Summary
Overview
Work History
Education
Skills
Timeline
Generic
Open To Work

Troy Mitchell

Belmont,CA

Work Preference

Job Search Status

Open to work
Desired start date: Immediately

Desired Job Title

Senior Quality Assurance ManagerQuality Assurance ManagerSenior Quality Assurance Specialist

Work Type

Full Time

Location Preference

HybridOn-Site
Location: Belmont, CA, US
Open to relocation: No

Salary Range

$130000/yr - $200000/yr

Summary

Highly motivated and detail-oriented Quality Assurance individual with 20 years of experience in Biotech, Pharmaceutical and Cell & Gene Therapy, possessing a strong eye for detail, an aptitude for problem solving and excellent work ethic. Proven ability to work independently on multiple projects and as part of a team to ensure compliance and success.

Overview

25
25
years of professional experience

Work History

QUALITY ASSURANCE ASSOCIATE III

Minaris Regenerative Medicine
Mountain View
01.2015 - 12.2025
  • Quality lead for multiple clients ensuring QA and cGMP compliance for all aspects of the programs to support clinical studies from Phase 1 to commercial phase.
  • Technical expert on client tech transfers and project close outs.
  • Supported internal and external audits for current and prospective clients and local regulatory agencies.
  • Initiated and managed QA walk-through program, ensuring site compliance and minimizing facility discrepancies.
  • Executed QA support on the floor and managed line clearance activities in Aseptic Processing Suites.
  • Perform QA review and approval of specifications, stability protocols, validation protocols and all associated reports.
  • Performed Batch Record review and ensured the safe disposition of cellular products in accordance with Minaris and/or client procedures and requirements with no delay to the patient which ensured deliverables met the highest standards of quality.
  • Reviewed and approved validation and qualification documents for compliance with cGMP.
  • Authored, reviewed and approved SOPs and other documents to ensure alignment with both internal Minaris procedures and client requirements.
  • Served as QA subject matter expert on CAPA and change control management, tracking and trending issues to meet client and internal timelines.
  • Provided QA support to cross-functional teams on the critical review and approval of varied documents in Veeva EDMS system to align with the correct workflow and reduced the time to perform the tasks.
  • Trained and mentored new QA Associates in addition to mentoring other department employees on event initiation, deviation investigation and root cause analysis.
  • Developed and maintained quality assurance processes for accession and labeling, improving product quality and supporting customer satisfaction.
  • Performed raw material inspection and release for use in manufacturing and within the facility.
  • Performed validation acceptance testing for implementation of Quality Systems Applications (ACE, Veeva).
  • Provided support to the QA Management in updating KPls and metrics.
  • Oversaw the QA responsibilities of contract cleaning company which included training, documentation review and QA audits.

SENIOR QUALITY ASSURANCE ASSOCIATE

Onyx Pharmaceuticals
South San Francisco
01.2013 - 03.2014
  • Reviewed manufacturing batch records for starting materials, drug substances (API), drug products, and finished packaged products from multiple Contract Manufacturing Organizations, ensuring adherence to compliance and quality standards.
  • Reviewed Clinical Packaging batch records for multiple Clinical Trial projects to verify quality and compliance with regulatory requirements.
  • Coordinated resolution of moderately complex deviations, Out-of-Specification (OOS) / Out-of-Trend (OOT) investigations, and other quality events to uphold product integrity and regulatory compliance.
  • Performed maintenance and closure activities of Quality Assurance operations systems such as Deviations, CAPAs, and Change Controls to support QA operations and ensure compliance with Onyx Standard Operating Procedures.
  • Facilitated communication with Onyx Subject Matter Experts (SMEs) and contract manufacturing organizations (CMOs) regarding quality issues, ensuring prompt corrections and resolutions.

QUALITY ASSURANCE SPECIALIST III

Gilead Sciences, INC.
Foster City
07.2007 - 05.2012
  • Oversaw operations for 6 CMOs across the US, Canada, and Europe.
  • Supported 3 US product launches.
  • Led commercial product disposition activities including review of batch records, quality control data, environmental monitoring and third party testing.
  • Approved master batch records, product specifications and analytical forms for all CMOs.
  • Performed approval, trending and timely closure of Deviations, Out of Specifications (OOS), Out of Tolerance (OOT), Corrective Action/Preventive Actions (CAPA) and Change Control Requests for all CMOs.
  • Resolved product complaints and reviewed deviations for all CMOs, maintaining compliance with quality standards.
  • Proofread and approved labeling (inserts, cartons, booklets, labels) for artwork updates and regulatory submissions.
  • Conducted bi-weekly meetings with CMOs and SMEs to identify and address quality issues, driving process improvements.
  • Led weekly meetings with supply chain to ensure efficient lot release with no impact to market inventory.
  • Participated in inspections and pre-approval investigations conducted by regulatory agencies and partner companies.
  • Trained new QA personnel on standard operating procedures, improving team competency and adherence to quality protocols.

QUALITY ASSURANCE SPECIALIST II

Vaxgen
South San Francisco
02.2006 - 05.2007
  • Provided QA support for daily manufacturing and operations, ensuring that all practices, policies and procedures related to quality and compliance met federal, company and other regulatory standards.
  • Conducted QA review of production documentation inside the plant (PIP), including production batch records and supporting documentation to ensure compliance with cGMPs and company policies and procedures.
  • Ensured initiation, timely closure and effectiveness of deviations, initiated and tracked CAPAs.
  • Created and revised SOPs to ensure cGMP compliance, addressing audit responses and deviation investigations.
  • Provided QA review and approval of change controls including impact and proper closure.
  • Performed final review and disposition of manufactured lots.
  • Conducted thorough incoming inspections of raw materials to verify quality standards before release.
  • Conducted routine manufacturing facility audits, encompassing logbook review, equipment cleaning, material labeling, segregation, safety observations, and overall compliance.
  • Developed and delivered training programs for new QA personnel to reinforce adherence to quality standards.

MANUFACTURING/COMPLIANCE SUPPORT

Alza Corporation
Redwood City
04.2003 - 11.2005
  • Revised and created SFPUs, work instructions, batch records, and forms, enhancing operational consistency and ensuring regulatory compliance.
  • Investigated process deviations and non-conformances, facilitating timely resolution and maintaining compliance standards.
  • Trained process operators on revised documents and procedures.
  • Performed Acceptable Quality Level (AQL) inspections.
  • Granted Line Clearance for manufacturing prior to any batch run.
  • Represented manufacturing in weekly meetings with QA to discuss outstanding items, deviations and batch metrics.
  • Performed Operational Area Start-up for facility.
  • Facilitated bi-weekly operations meetings to align production goals and address operational issues.
  • Scheduled manufacturing operations and supported lot changeovers, optimizing production flow and resource allocation.

PROCESS OPERATOR

Alza Corporation
Redwood City
04.2001 - 04.2003
  • Shift Lead - Operated rotary conversion packaging equipment to produce transdermal product in a GMP environment.
  • Monitored and adjusted process parameters to optimize product quality and ensure compliance with GMP standards.
  • Conducted in-process checks and collected samples for finished product testing to ensure compliance with quality standards.
  • Developed and implemented SOPs to ensure consistent product quality.
  • Maintained accurate and up-to-date process documentation.
  • Maintained calibrated devices such as balances and leak testers.
  • Coordinated communication among manufacturing, quality control, and logistics to streamline receipt of components and finished products.

Education

B.A. - Graphic Design

San Diego State University
San Diego
San Diego

Skills

  • CGMP compliance
  • Quality system implementation
  • Batch record review
  • Aseptic processing
  • Process improvement
  • CMO Management
  • Veeva Vault
  • NetSuite and SAP ERP
  • Attention to detail
  • Time management
  • Verbal and written communication
  • ACE Change Control

Timeline

QUALITY ASSURANCE ASSOCIATE III

Minaris Regenerative Medicine
01.2015 - 12.2025

SENIOR QUALITY ASSURANCE ASSOCIATE

Onyx Pharmaceuticals
01.2013 - 03.2014

QUALITY ASSURANCE SPECIALIST III

Gilead Sciences, INC.
07.2007 - 05.2012

QUALITY ASSURANCE SPECIALIST II

Vaxgen
02.2006 - 05.2007

MANUFACTURING/COMPLIANCE SUPPORT

Alza Corporation
04.2003 - 11.2005

PROCESS OPERATOR

Alza Corporation
04.2001 - 04.2003

B.A. - Graphic Design

San Diego State University

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Troy Mitchell