Summary
Creative and versatile results-oriented quality assurance and compliance professional with 11 years’ successful track record of working with multiple quality systems and manufacturing processes within various pharmaceutical and biotechnology environments. Adaptable and innovative, with the ability to balance multiple priorities, manage change, and effectively deal with the most challenging situations.
Experience
Quality Assurance Specialist March 2010 – Present
Plant Support Quality Assurance
Amgen Inc., Longmont, Colorado
Responsibilities
•Provided QA oversight of all facets of facility and utilities systems.
•Reviewed and approved maintenance work orders, job plans.
•Reviewed and approved equipment and cleaning validations.
•Quality Owner for change control, nonconformance, and CAPA records.
•Quality support of new product introduction activities.
•Plant Support QA group Operational Excellence lead.
•Quality representative for various projects ranging from the commissioning and validation of new equipment to site-wide building management system upgrades.
Achievements
•Provided QA oversight and acted as subject matter expert, during a four-month assignment in Puerto Rico, for the successful site-to-site technology transfer of denosumab (trade name Prolia).
Quality Assurance Specialist March 2008 – March 2010
Senior Quality Assurance Associate March 2006 – March 2008
Quality Assurance Associate III April 2005 – March 2006
Manufacturing Quality Assurance
Amgen Inc., Boulder, Colorado
Responsibilities
•Provided on-the-floor quality assurance support to manufacturing operations.
•Reviewed and approved batch production records, equipment clean and use logs.
•GMP document approval, including SOP, forms, production records, etc.
•Involved with lot disposition activities, including review of nonconformance, LIMS results and COA, change control status, batch status changes, and new product launch activities.
•Led cross-functional process improvement project teams that utilized LEAN Manufacturing, Six Sigma, and CQI concepts and tools.
•Led periodic manufacturing area, procedure & process audit teams.
•Assessed manufacturing production areas for regulatory compliance and inspection readiness and trained area staff on cGMP and compliance.
•Involved with various regulatory inspection teams to assess compliance risk issues and implement corrective measures.
Achievements
•Successfully implemented a manufacturing operation audit program. Designed and implemented database for program to improve efficiency, interdepartmental communication, and on-time closure of observations.
•Successful implemented of a site-wide equipment log audit program, and successfully defended the approach in several regulatory agencies and internal audit inspections.
•Managed a cross-functional, site-wide process improvement project related to equipment logs that resulted in a continual departmental cost savings of $405,000/year.
•Managed a follow-up process improvement project that resulted in further departmental cost savings of $51k/year.
Quality Assurance Associate II March 2003 – April 2005
Plant Quality Assurance
Amgen Inc., Thousand Oaks, California
Responsibilities
•On-the-floor quality assurance support to manufacturing operations.
•Review and approval of batch production records, equipment clean and use logs.
•GMP document approval, including SOP, forms, production records, etc.
•Worked with manufacturing to correct compliance, process, procedural and documentation gaps identified by audit teams.
•Provided cGMP training for new QA and manufacturing personnel.
Achievements
•Instrumental in PQA batch record review team reaching and maintaining 5-day batch record review cycle times.
•Instrumental in PQA reaching and maintaining disposition cycle time goals.
•58% nonconformance rate reduction.
•Designed and implemented batch record review tracking database and associated forms, used for error trending, and the reduction of batch record review and disposition cycle times, and increased the QA group efficiency.
Quality Assurance Associate II 2002 - 2003
Process Compliance
Baxter Healthcare Inc., BioScience, Los Angeles, California
Responsibilities
•Provided on-the-floor quality support to manufacturing operations.
•Reviewed and approved batch production records, supporting documents and logs.
•Performed audits of manufacturing operations and helped drive corrective actions.
•Nonconformance investigation and CAPA approval and trending.
•Tracked and performed trend analysis for quality indicators and reported results to the site management review meetings.
Quality Assurance Specialist 2000 - 2002
In-Process Support Laboratories, Quality Control
Baxter Healthcare Inc., BioScience, Los Angeles, California
Responsibilities
•In-process testing of product intermediate, final products, buffers, media, raw materials and water.
•Prepared laboratory standards, controls, reagents and established ranges.
•Reviewed and approved analytical test data, reports and final results.
•Assisted with analytical instrument validation activities.
Education
Cell and Molecular Biology, Bachelor of Science 2000
California State University Northridge, Northridge, California
Technical & Software Proficiencies, Training and Other Skills
Technical & Software Proficiencies
•Aseptic Processing
•Cell Culture and Fermentation Scale-Up processes (mammalian and bacterial cell lines)
•Protein Recovery and Purification processes
•Sterile Filtration and Filling
Training & Additional Languages
•Colorado State University Project Management Certificate Program
•Baxter Healthcare Corp. Six Sigma Quality Engineer
Other Skills
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•Proficient with industry software such as LIMS, SAP, TrackWise, Maximo
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•Fluent in Spanish