Quality Control Manager

Jorge Lopez

Thousand Oaks, CA ***** 805-***-****

********@*****.*** linkedin.com/pub/jorge-lopez/7/674/3ab

Summary

A Quality Control Professional with more than 15 years experience in laboratory environment. Extensive knowledge of laboratory management, including coordination and execution of testing, method development, method validations/transfers, compliance assurance, and personnel responsibilities. Proven success in managing internal and external audits, assessing and remediating compliance issues.

Establish new Laboratories

Chromatography Data Systems (Empower, others)

Computer Validation

LIMS Systems

Laboratory Management

Stability Programs Management

SOP Authoring

Quality Management System for NC/CAPA (TrackWise)

Compliance Auditing

Method Validation/Transfer

Method Development

Professional Experience

BAXTER BIOSCIENCE, Los Angeles, CA 2012-2014

Quality Control Supervisor/Manager

Oversee all aspects of the biochemistry laboratory testing in support of release of in-process and finish products for Los Angeles site. Provided technical and compliance support for NC/CAPA investigations and regulatory agency audits.

Managed the day-day operation of the lab and emerging issues.

Managed laboratory related NC and CAPA investigations.

Set direction for all direct reports consistent with department need and goals.

Implement and continuously improve quality systems to ensure compliance with current regulations.

Performed routine compliance checks to ensure adherence to Quality procedures and processes.

Managed and planned performance improvement initiatives.

Implemented a safe working environment for employees.

FUSION PHARMACEUTICALS, Camarillo, CA 2007-2011

Quality Manager

Oversee all aspects of the Fusion’s Quality Systems in support of release of in-process and finish products. Managed and planned performance improvement initiatives, including knowledge bases and learning interventions.

Designed and authored a set of GMP compliant procedures which led to licensing of a pharmaceutical manufacturing facility.

Designed and managed the stability program associated with drug substances and products.

Implemented specifications and product expiry, based on stability studies and regulatory guidelines.

Audited and inspected contract manufacturers.

Managed the document change control program.

Implemented and managed the NC/CAPA Quality System.

Led Fusion’s California State Department of Health and FDA inspection with no observations.

Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.

Additional Experience

AMGEN INC., Thousand Oaks, CA 1991-2007

Quality Control Specialist (2002-2007)

Quality Control Manager (1997-2002)

Quality Control Supervisor (1994-1997)

Research Associate III (1991-1994)

Oversee all aspects of the Amgen’s Chemistry Quality Control Laboratory in support of release of in-process, stability and finish products. Managed and planned performance improvement initiatives, including knowledge bases and learning interventions in order to meet personal and corporate goals.

Management of 20+ staff members in one laboratory facility.

Direct the transfer of analytical method from and to external Amgen sites and contract laboratories

Design/Coordinated method validations, qualifications of analytical methods and instruments.

Coordinated and lead investigations of NC and CAPA’s.

Audited and inspected subcontractor facilities, including their laboratories.

Set up the laboratory infrastructure for cGMP stability testing of small molecule products at Amgen.

Key role player in establishing Amgen’s Puerto Rico chemistry laboratory and training of personnel.

Initiated Amgen’s Quality Control excipients and raw material clearance assays testing lab.

Validated analytical methods and trained lab associates in appropriate techniques and procedures.

Performed tests associated with the release of in-process, stability and finished products.

Responded to FDA inspectors for all laboratory issues and concerns.

Education

AA, Associate in Arts, General Education, Moorpark College, Moorpark, CA

Numerous seminars in analytical instrumentation, regulatory guidelines, and effective management

Technical Skills

Intimate familiarity with state of the art analytical instrumentation, including but not limited to HPLC, IC, GC, Particle Size, FTIR, AA, ICP, TOC, FIA, Dissolution, Disintegration.

Languages

English and Spanish

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