Quality Technician

MICHELLE VERZOSA

Phone: 619-***-**** ● E-Mail: ********.*********@*****.***

SUMMARY

Detail oriented Quality Assurance Professional within the biotechnology, medical device and pharmaceutical industry with expertise in product complaint handling of various diabetes products. Innovative strategist with proven ability to identify process improvement and effectively train internal personnel, on various company products. Successful in analyzing and streamlining procedures to reduce turn around time. Proficient in various robust Material Requirements Planning (MRP) system databases.

SKILLS

* Author, Revised, Review Controlled Documents

* Internal Audit

* Non-conformance & Corrective Actions

* GXP Procedures: cGMP, GLP

* Product Complaint Investigation

* Database Expert GPCMS, Oracle AERS, Trackwise Systems

* ISO 9001/ISO 13485

* Attended Product Complaint Conference in 2013

PROFESSIONAL EXPERIENCE

ASTRAZENECA PHARMACEUTICALS LP, San Diego, CA 2008 - Dec 2014

(Formerly Amylin Pharmaceuticals, LLC a wholly owned subsidiary of Bristol-Myers Squibb. Bristol-Myers Squibb purchased Amylin Pharmaceuticals, Inc. AstraZeneca then purchased the diabetes franchised from Bristol-Myers Squibb.)

Quality Analyst II 2010-2014

Subject Matter Expert (SME) for complaint lab investigation, performing root cause analysis, determining appropriate corrective actions to resolve the issues for US, global markets and clinical products on returned product and paper base complaints that have no returned product. Maintained constant interaction with Contract Service Providers (CSP) and Contract Manufacturing Organization (CMO) outside the organization and multi functional groups within the company, to follow up on detailed investigations due to non-conforming products to ensure investigations met specifications. Complied with request of FDA or other regulatory authorities during audits, resulted in no major findings. SME for quality systems, participated in validation activities and complaint database design. Revised Standard Operating Procedures (SOP’s) through the electronic document management system (EDMS). Involved in cross-functional discussion gaining alignment on complaint escalation involving other functional areas, which resulted in the initiation of Corrective and Preventative Actions (CAPA) to document decisions and detailed investigations.

* Created and designed a desktop safety poster for needle handling which is currently in use to decrease needle incidents in the lab.

* Team member in multiple Lean Management projects and Kaizens to continuously improve complaint-handling processes; decrease the turn around time for complaint handling.

* Trained personnel, internally and externally, on products and process handling during company transition.

* Created detailed training document for new hires and led the hands-on complaint-handling training investigations as a result of company acquisition.

Quality Analyst I 2008-2010 Executed triage, investigation and data entry of clinical and commercial complaints for US and non-US markets that were entered into various quality systems per SOP. Collaborated in identifying and troubleshooting issues to provide quality and reduce inefficiencies at the call center. Facilitated training development of the call center personnel for various company products. Provided recommendations for business improvement processes as they were identified during the analysis, tracking, and trending of quality review inputs.

* Major key player in the group to prevent complaint backlog when other colleagues were involved in other projects resulting in becoming the lead investigator in clinical complaints.

* Managed workload in a fast-paced environment, processing over 20 product complaints lab investigations to conclusion on a daily basis, which led to the elimination of the product complaint backlog within 2 months of start date.

EBIOSCIENCES INC, San Diego, CA 2005-2008

QC Associate II

Responsible for daily work and assignments of the Quality Control team, including scheduling, analyzing and approving antibody QC test to ensure timely release. Conducted cultured cells to provide team with appropriate test materials. Prepared and reviewed Certificate of Analysis. Performed surface and intracellular staining experiments.

* Monitored and improved test turnaround times by preparing detailed reports of products in-house.

* Participated in weekly meetings regarding status update of products to ensure timely release.

BD BIOSCIENCES PHARMINGEN, San Diego, CA 2004-2005

Technician I:

Performed QC of Antibodies to ensure products met all specifications prior to release. Packaged and assembled biomedical research agents and kits with applications for cell biology, immunology and molecular biology.

* Observed machine operations to ensure quality and conformity of filled/packaged products to standards.

* Involved with group projects of large-scale bottling and assembling.

EPOCH BIOSCIENCES, San Diego, CA 2000-2003

Manufacturing Technician II:

Performed HPLC, PAGE and final QC routines of oligonucleotide. Performed final QC of oligonucleotide. Aided in final packaging, labeling and shipping. Assure all products and documentations met release criteria before shipping.

* Strengthened relationships as a CMO by providing daily communication regarding updates and tracking of in-house orders.

* Maintained a workload in a fast pace environment to ensure products met timed deadlines.

* Implemented the use of Nap-10 columns for a more efficient enzyme conjugation prior to HPLC purification

EDUCATION

Bachelor of Science, Biology, San Diego State University- San Diego, CA

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