Quality Control R D

Zulaika Davison

linkedin.com/in/zulaika-davison

Fremont, CA m: 510-***-**** *************@*****.*** Career Profile

Experienced Quality Control Specialist with a background in biopharmaceutical testing, validation, and ensuring compliance with FDA, GLP, and GMP standards. Proven ability to improve lab operations, collaborate effectively with manufacturing and research teams, and enhance process efficiency. Skilled in developing and transferring new assays to the QC lab, as well as performing IQ/OQ/PQ validations.

Core Competencies

Analytical Testing & Method Development

• Performed 500+ GMP-compliant release, stability, and in- process tests for FDA-approved products.

• Analyzed R&D samples to support product development.

• Supported method transfers for 10+ major client assays, ensuring seamless integration and compliance.

• Ensured compliance and validated new analytical

methods.

• Conducted Pierce 660-nm Protein Assays, ELISA, wet chemistry, gel electrophoresis, pH, and absorbance assays.

• Led IQ/OQ/PQ validations for new and existing methods. Technical Skills

• Analytical Testing: HPLC, GC, CE, ELISA, N-terminal sequencing, AAA, Erytra, Pierce

• Method Development & Validation

• Maintenance and calibration of laboratory instruments and equipment

• IQ/OQ/PQ Validation

• Regulatory Compliance: FDA, EMA, GMP/GLP

Compliance & Documentation

• Documented all testing activities in compliance with GMP and GLP standards.

• Wrote, revised, and maintained SOPs and test methods.

• Reviewed and verified data for accuracy, compliance, and completeness.

• Supported regulatory submissions with validated data in alignment with FDA and EMEA requirements.

• Utilized GLIMS for sample tracking, data management, and regulatory reporting.

Collaboration, Safety & Leadership

• Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs

• Provide lab personnel training and supervision

• Conduct investigations and lead root cause analysis

• Active member of the Emergency Response Team (ERT), ensuring lab and personnel safety through rapid

response to incidents and participation in regular safety drills

Vendor Relations & Assay Transfers

• Coordinated with vendors before transferring assays to the company, ensuring compatibility with internal

standards and seamless integration into the QC lab.

• Managed procurement of laboratory instruments and equipment, ensuring alignment with lab needs and

budget.

• Worked closely with vendors to evaluate products, negotiate prices, and ensure timely delivery.

Zulaika Davison Page 2

Analytical Equipment Experience

Protein & Amino Acid Analysis:

• AAA – Hitachi Amino Acid Analyzer

• NTS – Procise N-terminal Sequencer

Chromatography Techniques:

• HPLC – High-Performance Liquid Chromatography

• GC – Gas Chromatography

• CE – Capillary Electrophoresis (PA 800 Plus Analysis System) Spectroscopy & Analytical Tools:

• SoloVPE PLUS System – Slope Spectroscopy

• UV-Vis Spectrophotometry

• BioTek Microplate Reader

• pH Meter

Clinical/Diagnostic Instruments:

• Erytra Blood Typing Analyzer

Professional Experience

GRIFOLS, EMERYVILLE, CA, DECEMBER 2014 TO MARCH 2025 QUALITY CONTROL SPECIALIST

• Performed GMP-compliant release, stability, and in-process routine testing for proteins and antigens.

• Executed validated analytical methods (ICH, USP) and supported method optimization with QA and R&D.

• Authored/reviewed SOPs, validation protocols, and method transfer reports to ensure regulatory compliance.

• Transferred client assays into QC, including qualification, documentation, and analyst training.

• Conducted advanced testing (HPLC, GC, amino acid analysis, UV/VIS, N-terminal sequencing

• Operated and maintained analytical instruments

• Maintained, and operated Erytra for blood group antigen/antibody testing

• Supported FDA, EMA, and ISO audits with technical information and process overviews.

• Tracked KPIs, led investigations, and drove continuous improvement of QC workflows and systems.

• Partnered cross-functionally on CAPAs, deviations, and product lifecycle activities.

• Trained junior analysts, improving lab efficiency, data accuracy, and compliance. NOVARTIS, EMERYVILLE, CA, JANUARY 2005 TO JANUARY 2014 Analytical Operations Analyst III

• Performed peptide and antigen analysis in a GMP-compliant lab

• Conducted protein characterization via N-terminal sequencing and AAA

• Qualified analytical instruments and validated methods

• Troubleshot complex instrumentation and supported rapid project timelines CHIRON CORPORATION EMERYVILLE, CA, DECEMBER 1997 TO MARCH 2005 Analytical Operations Analyst I-II

• Developed HPLC methods for novel antigen analysis

• Supported therapeutic and diagnostic projects with accurate data reporting

• Collaborated with scientific teams to refine analytical strategies

• Enhanced lab performance through continuous process improvements Education and Credentials

• B.A. in Biochemistry/Molecular Biology University of California, Santa Barbara

• First Aid, CPR, and Emergency Response Certified

• Member, Emergency Response Team (ERT)

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