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Quality Engineer Manufacturing

Daly City, California, United States
April 22, 2019

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Arjay Ferrer

Daly City, CA 628-***-****

Professional Summary

Motivated Quality Assurance Associate with years of experience in Quality and Manufacturing including supporting Chemistry, Manufacturing and Controls (CMC) of biologic and solid dosage drug substance for clinical and commercial use.

Work History

Quality Assurance Associate II, 08/2018 to Current

Biomarin Pharmaceutical Inc – Novato, CA

Reviewed Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) to ensure that internal documents are aligned to regulatory filings of clinical products.

Responsible for approving drug substance manufacturing changes with regulatory restrictions using product release controls (PRC).

Supported Chemistry, Manufacturing & Controls (CMC) for the releases of new commercial products in the US and EU.

Approved master batch records (MBRs) and standard operating procedures (SOPs) for drug substance manufacturing.

Quality Assurance Associate I, 08/2017 to 08/2018

Biomarin Pharmaceutical Inc – Novato, CA

Responsible for gap analysis between Biologics License Application (BLA) and internal documents in preparation for commercial launch in the US.

Trained QA personnel in batch record and lot release of clinical and commercial batches.

Supported cross functional activities in preparation for process performance qualification (PPQ) campaign.

Reviewed and approved change controls for manufacturing of drug substance.

Performed visual inspection of vials and labeling for drug product releases.

Reviewed manufacturing deviations and associated corrective action and preventative actions (CAPAs).

Senior Quality Specialist, 01/2016 to 08/2017

Biomarin Pharmaceutical Inc – Novato, CA

Reviewed and released drug substance lots for commercial use.

Trained QA personnel in batch record review and lot release of clinical and commercial lots.

Provided QA support to audit team during regulatory inspections.

Performed risk assessments to allow the shipment of drug substance under quarantine.

Supported technical transfer of new product introduction from development to large scale manufacturing.

Quality Specialist, 08/2015 to 01/2016

Biomarin Pharmaceutical Inc – Novato, CA

Reviewed and approved manufacturing batch records.

Released drug substance lots for clinical use in the US and EU.

Prepared lot release and batch record review metrics for Senior Management.

Supplier Quality Coordinator, 09/2013 to 02/2014

Genentech Inc. (contract) – South San Francisco, CA

Generated annual audit schedule for all Roche global suppliers using Trackwise audit.

Trended supplier related discrepancies for supplier collaborations and continuous improvements.

Established work instructions and business processes for new system implementations.

Performed gap analysis on large data in preparation of implementing a new audit system.

Quality Engineer I, 05/2013 to 09/2013

Impax Laboratories Inc – Hayward, CA

Investigated manufacturing deviations and proposed product dispositions to Senior Management.

Established corrective actions and preventative actions (CAPAs) and tracked their effectiveness using Trackwise.

Trended and analyzed manufacturing deviations for continuous improvements.

Prepared annual product reviews (APRs) per the assigned schedules.

Manufacturing Technician, 08/2010 to 05/2013

Impax Laboratories Inc – Hayward, CA

Prepared production documents such as standard operating procedures (SOPs) and manufacturing batch records.

Performed manufacturing processing of small molecule products.

Qualified in equipment which included Clean in Place (CIP) and handling or hazardous materials.

Inspected finished products for quality and adherence to customer specifications.


Bachelor Of Science In Chemical Engineering: 2009

University Of California - San Diego - La Jolla, CA

Master Of Science In Regulatory Science: 2018

John Hopkins University - Baltimore, MD

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