Christopher Park Email & Phone Number

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%

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

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

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

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

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