QA Biotech/Pharma Systems Engineer

Professional Experience:

March **** – July ***0: Genzyme Drug and Biomaterial R&D Waltham, MA

Quality Systems Engineer II 07/08 - 07/10

Quality Systems Engineer 07/06 - 07/08

Quality Assurance Stability Coordinator 04/05 - 07/06

Quality Assurance Inspector II 03/02 - 04/05

Primarily focused on identifying processes to improve and streamline multiple quality systems. Utilized Project Management techniques within the quality department to define and manage timelines for QA systems projects.

Below are some highlights from my career at Genzyme.

• Acted as the project manager in order to plan, coordinate, monitor, and close projects conducted within the Quality Assurance department

• Project lead for the validation of the MasterControl Process system and assisted with the validation of the MasterControl Documentation system

• Worked as part of multi-disciplinary team to establish the new kilo-scale manufacturing facility; Received a VP award for my efforts and initiative with this process

• Worked with a team to introduce and implement a new training software system into the site (Plateau).

• Executed internal system audits and external vendor audits

• Maintained and improved the existing stability system. Tracked all stability related functions from creation of protocol to submission of final report for all active projects. Revised the existing stability system to create a system that was consistent across all projects to ultimately increase efficiency

• Worked to revise the existing shipping system to bring the site within compliance of all necessary DOT, IATA, and cGMP requirements for the movement of material between contract vendors, contract labs, and domestic and international Genzyme sites

• Worked with various facets of document control systems in compliance with cGMP requirements

October 2001 – March 2002: Avecia Biotechnology, Inc Milford, MA

Document Control Specialist

• Acted as lead coordinator of a quality systems project to bring existing systems to within GMP standards; Delegated and provided guidance and supervision to other quality systems team members

• Exercised judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

• Effectively communicate problems, observations, and conclusions to personnel from different functional groups and resolved Quality Systems issues

• Designed a tracking database to support the quality unit

January 2001 – September 2001, XOMA Biotechnology Berkeley, CA

Document Control Associate

• Chaired weekly documentation meetings attended by analysts, operators, managers, and directors

• Facilitated the documentation portion of a new product line as well as the successful startup of a new pilot plant facility on an aggressive schedule to successfully meet deadlines

• Participated in various projects in support of department and corporate goals, such as internal audits and validation of databases

• Created and revise GMP and GLP documents such as production batch records SOPs, SPECs, etc for departments throughout the company

• Maintained several validated databases used in issuing, tracking, and reporting

• Performed internal audits on existing QA systems

September 2000 – January 2001, Insite Vision Alameda, CA

Document Control Specialist /cGMP + cGLP certified

• Provided support for successful regulatory agency audit

• Archived all cGMP and cGLP documentation, including but not limited to clinical files, regulatory filings and amendments, as well as all manufacturing documentation

• Supported a manufacturing process consisting of over 20 batch record requests per week

• Revised, reformatted, rewrote, and issued new and existing documents as required, tracked distribution and audit controlled documents throughout the company

March 1998 – January 2000, Cookson, AMPM division Warwick, RI

Senior Laboratory Associate

• Performed routine analysis to support scientists and the Quality Department with testing, data collection, trending, and documentation of experimental and qualified products

• Supported experimental product design, development, and release into manufacturing

• Performed preventive maintenance, calibration, and troubleshooting of equipment for three analytical laboratories

• Responsible for the training, supervision, and delegation of work between junior laboratory associates

Education:

Community College of Rhode Island AS in Chemistry Warwick, RI

Northeastern University – Currently enrolled for a BS in Leadership 60% complete Boston, MA

Professional Skills:

Windows OS, MS Office, MS Access, MS Project, Word Perfect, Adobe Acrobat Professional

RDM (Resource Data Management), Visio, Calman 3, MasterControl, Plateau, Livelink

IATA/DOT certified; Proficient in cGMPs and cGLPs

Various analytical equipment

Memberships:

Society of Quality Assurance, Massachusetts Biotechnology Council

REFERENCES AVAILABLE UPON REQUEST

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