Jennifer Otero Santiago
Toa Baja
Summary
Accomplished Quality Assurance professional with extensive experience in quality assurance and quality control operations within the biopharmaceutical industry. Demonstrated proficiency in ensuring compliance with cGMPs, GLPs, and regulatory guidelines. Proven track record of effectively managing and enhancing quality systems, leading audits, and providing technical guidance across manufacturing and support operations. Committed to upholding right-the-first-time quality standards through proactive risk management and continuous process improvement.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Manager, Senior Quality Assurance Scientist
Bristol Myers Squibb
01.2022 - Current
- Lead the review and oversight of cGMP practices in manufacturing and support operations to ensure compliance with regulatory and corporate standards
- Provide technical expertise and guidance in reviewing documents, including batch records, packaging procedures, and operational processes across non-sterile manufacturing areas
- Conduct quarterly, monthly, weekly, and daily audits of production processes, identifying potential areas of improvement to ensure adherence to quality standards
- Support creation, implementation, and training of SOPs to ensure compliance with applicable regulations, including Good Distribution Practices (GDP) and electronic systems
- Oversee and ensure proper documentation for quality control and regulatory reviews, mitigating risks related to compliance issues
- Drive initiatives for continuous improvement in quality and compliance metrics within manufacturing operations
Sr. Associate Quality Control Biochemistry Lab
Spectraforce Technologies, Amgen Manufacturing Limited
09.2018 - 10.2019
- Responsible for compendial and non-compendial testing methods, providing accurate and reliable analytical results in compliance with regulatory and internal requirements
- Played a key role in development and execution of Biovia LES procedures, ensuring rigorous control over analytical methods
- Led troubleshooting and investigations in Quality Control, identifying and resolving product and system discrepancies
- Performed method transfers and executed validation protocols for key analytical techniques
- Collaborated with cross-functional teams to ensure compliance with cGMP and internal policies, ensuring timely completion of quality-related tasks
QC Lab Analyst in Bioanalytical Lab
Proassets Inc. for Bristol Myers Squibb
07.2016 - 09.2018
- Delivered precise biological product testing, including in-process, finished products, complaint, and stability samples, ensuring compliance with SOPs and regulatory standards
- Acted as Subject Matter Expert (SME) in protein analysis using SDS-PAGE and protein concentration methods and provided training on these techniques
- Played key role in conducting laboratory audits, focusing on adherence to 5S methodology and maintaining housekeeping standards
- Provided technical guidance to teams and trained new hires in analytical techniques, enhancing operational efficiency and reducing errors in product analysis
- Supported execution of installation and operational qualification (IOQ) for key laboratory equipment to meet operational standards
Quality Control Associate Biochemistry Lab
Spectraforce Technologies, Amgen Manufacturing Limited
01.2015 - 06.2016
- Conducted laboratory testing for compendial and non-compendial methods, ensuring the integrity and compliance of test results with internal and external standards
- Oversaw and supported training efforts as a Certified Instructor-Trainer in appearance, color, and clarity testing
- Worked closely with the analytical data review team to verify compliance with company policies and regulatory requirements
Education
Bachelor’s Degree - Biology
University of Puerto Rico
Bayamón, Puerto Rico12.2011
Skills
- Quality Assurance
- Regulatory Compliance
- Decision-making
- Staff training and development
- Verbal and written communication
- CGMP / GDP / GLPs
- Leadership / Team Collaboration
- Analytical Expertise and Data Review
- Method Transfer / Validation
- Auditing
Certification
Certification in GMP Compliance
Languages
English
Spanish
Software
SampleManager LIMS
QUMAS
Veeva Vault
SAP
Syncade (DCA)
Electronic Batch Record
Biovia LES
Biovia Consumable Inventory Management System
Timeline
Manager, Senior Quality Assurance Scientist
Bristol Myers Squibb
01.2022 - Current
Sr. Associate Quality Control Biochemistry Lab
Spectraforce Technologies, Amgen Manufacturing Limited
09.2018 - 10.2019
QC Lab Analyst in Bioanalytical Lab
Proassets Inc. for Bristol Myers Squibb
07.2016 - 09.2018
Quality Control Associate Biochemistry Lab
Spectraforce Technologies, Amgen Manufacturing Limited
01.2015 - 06.2016
Certification in GMP Compliance
Bachelor’s Degree - Biology
University of Puerto Rico
Similar Profiles
Megan KennisonMegan Kennison
Senior Therapeutic Area Consultant Orencia at Bristol Myers SquibbSenior Therapeutic Area Consultant Orencia at Bristol Myers Squibb
Miguel LopesMiguel Lopes
QC Senior Specialist at Bristol Myers SquibbQC Senior Specialist at Bristol Myers Squibb
DAWIN RODRIGUEZDAWIN RODRIGUEZ
EHS Specialist Assigned to Bristol Myers Squibb at Bristol Myers SquibbEHS Specialist Assigned to Bristol Myers Squibb at Bristol Myers Squibb