Christopher Park Email & Phone Number

Billerica, Ma, Us

Bedford, Massachusetts, United States

Cambridge, Massachusetts, United States

Quality professional in Gene Therapy

Cambridge, Massachusetts, United States

Quality professional in Gene Therapy

Bedford, Massachusetts

Allston, Ma

• Collaborated in inspection readiness efforts for 2017 FDA audit• Led and managed an individual leadership project for deviation cycle time improvement• QA Approved Deviations, Lab Investigations, CAPAs, and Change Control in Trackwise• Facilitated risk assessment processes• Collaborated as subject matter expert for QA in the change control process• Created and Implemented a training program for technical writing reducing excess investigational word count by 40% site-wide and optimizing deviation cycle time by 160%• Produced leading review results for deviation closure in 2015 and 2016Accomplishment:At Genzyme, I have had the privilege of leading and experiencing success in continuous improvement projects. One such example is leading a cross-functional review project with a team of 5, resulting in a 90% reduction of a backlog of 155 documents in 2 weeks. During this project, I had assumed the role of a supervisor delegate.Furthermore, the Individual Leadership Project previously discussed, provided me an opportunity to apply my learnings from the MSEM program at Genzyme. In this project, I worked closely with a senior continuous process improvement project manager to build a small database capturing Deviation Cycle Times Reduction data. Through the project, we were able to examine and establish the underlying relationships of factors impacting deviation cycle times.

Allston

• Contained, reviewed, and closed time sensitive deviations, CAPAs, and Lab Investigations• Successfully led a record review blitz resulting in a 90% reduction in a backlog of 155 media records in 2 weeks• Successfully provided training to new QA employees • Participated and contributed on QA continuous improvement project with 2nd shift• Participated in other QA continuous improvement project teams such as Culture of Quality• Reviewed testing results in iLIMS• Used MFGPro (Management Inventory), Trackwise, and Catsweb on a daily basis for cGMP record review• Reviewed Batch Records for manufacturing including buffer, media, and cell culture sometimes exceeding targets on the 2014 scorecard

Allston

• Reviewed EM (environmental monitoring) and critical utility deviations for WFI (water for injection) systems, RO (reverse osmosis) systems, and QC lab water systems • Reviewed QC micro deviations• Initiated deviations for EM and critical utility excursions• Reviewed CAPAs• Provided Quality System support through review and quality system feedback• Initiated Phase II investigations for product related OOA and OOS results• Familiarized with Genzyme/Industry sanitization and microbial control practices

Devens

• Supported review and quality systems improvements for commercialized API including Decitabine, Bromfenac, and Polymedix• Reviewed and Approved Executed Batch Records in a cGMP environment• Revised and approved Master Batch Records• Used Trackwise database to review deviations and investigations• Reviewed, revised, and approved QC standards in CISPRO database for product release testing• Created, Reviewed, and Approved COAs• Initiated Change Controls• Conducted product changeover cleaning inspections• Obtained knowledge on DMF and regulatory filing

North Billerica

• Performed Isotope Identification tests within a cGMP regulated manufacturing environment• Ran HPLC testing of benzyl alcohol in product samples• Executed Radionuclidic Identification and Purity Tests on product samples.• Conducted data entry into LIMS system within a cGMP environment • QC testing in cGMP environment• Verified reports and documents for completeness and accuracy• Acquired practice in the use and scope of SOP’s• Reviewed cleaning logs, calibration records, and charts

Master'S Degree, Engineering/Industrial Management, 3.5

Master'S, Regulatory Affairs (Drugs, Biologics, And Medical Devices), 3.8

Activities and Societies: Presidential Nomination for Sigma Epsilon Rho Honor Society in 2010.

B.A., Bcmb