Open to opportunities

Paige Favela

@paigefavela

I strengthen FDA-regulated quality systems, batch release, investigations, and compliance across pharmaceutical and nutraceutical manufacturing.

United States

Message

What I'm looking for

I'm looking to continue strengthening quality systems, compliance, investigation management, batch release, and continuous improvement in an FDA-regulated manufacturing environment.

Results-driven Quality Assurance professional with 8+ years of experience in pharmaceutical and nutraceutical manufacturing environments. Proven expertise in Quality Management Systems (QMS), GMP/GxP compliance, batch record review, deviation management, CAPA oversight, and regulatory inspection readiness. Demonstrated ability to lead cross-functional quality initiatives, drive continuous improvement, and maintain a culture of compliance in high-stakes FDA-regulated settings.

Experience

Work history, roles, and key accomplishments

Current

Senior Quality Assurance Specialist

Current

Bristol Myers Squibb / ROIS

May 2021 - Present (5 years 5 months)

Provide quality guidance to ensure safety, quality, identity, potency, and purity of products. Oversee Quality Management System including change controls, deviations, complaints, and CAPAs, and conduct root cause analysis investigations.

Quality Management Systems GMP Change Control Deviation Management CAPA Root Cause Analysis Batch Record Review SOPs Vendor Management Training Process Improvement

Current

Senior Quality Assurance Specialist

Current

Bristol Myers Squibb

May 2021 - Present (5 years 5 months)

Provide quality guidance to ensure safety, identity, and purity of products. Oversee quality management systems, conduct audits, and support compliance with GMPs.

Quality Assurance GMP Audit Root Cause Analysis CAPA Change Control SOPs Compliance

Data Entry Specialist, Contract Worker

Bristol Myers Squibb / ROIS

Nov 2020 - May 2021 (6 months)

Generated and updated documents within document management system to ensure compliance. Improved data accuracy by communicating with departments and translating data into LIMS.

Data Entry Document Management LIMS Process Improvement

Quality Assurance Associate

Medivant Healthcare

Apr 2020 - Oct 2020 (6 months)

Ensured thorough and timely investigations into deviations and change controls. Issued batch records and associated forms to production as needed for accurate documentation.

Quality Assurance Deviation Management Change Control Batch Records Documentation SOPs QMS Quality Management Systems Investigation Process Validation Training

R&D Technical Documentation Associate / HPLC Chemist

Arizona Nutritional Supplements

Aug 2018 - Apr 2020 (1 year 8 months)

Researched raw materials and maintained technical specifications. Performed testing of raw materials and finished products using HPLC/UPLC machines.

UPLC Documentation Research Testing

Analytical Chemist II

Casa Grande

Jun 2017 - Aug 2018 (1 year 2 months)

Ensured compliance with regulatory standards and engaged in Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Utilized HPLC and GC-MS techniques for precise analytical measurements and quality control, and assisted in training personnel.

HPLC GC MS GLP GMP Quality Control Analytical Chemistry Training

Analytical Chemist II

Abbott Nutrition

Jun 2017 - Aug 2018 (1 year 2 months)

Affirmed compliance with regulatory standards while engaging in GLP and GMP. Utilized HPLC and GC-MS techniques for precise analytical measurements and quality control.

GC MS GLP GMP Quality Control Training Batch Correction