Quality

Arpit Patel

****, *********** *** ****, **********, PA 18902 Ph: 732-***-**** ********@*******.***

Professional Summary

In-depth knowledge of cGMP, regulatory industry, and corporate guidelines and requirements. Qualified in identifying opportunities to optimize the use of available resources and consistently deliver successful outcomes. Proven leadership skills with the ability to provide guidance and mentorship to junior staff to achieve business objectives and manufacturing goals. Meticulously detail-oriented and organized with expertise in analysis, inspection and equipment functionality.

Core Competencies

Root Cause Analysis by various investigation tools

Hands on leadership and supervision

Project planning and execution

Breaking complex tasks into manageable segments

Resource Allocation and Management

Experience

Scientist II - Team Lead, Quality Assurance June 2015 to Current

Ortho Clinical Diagnostics Raritan, NJ

Six Sigma Yellow Belt Certified.

Received recognition for meeting and exceeding business goals and performance expectations.

Provide support during FDA inspections.

Spreadsheet validation.

Execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Perform complaint investigations, Out Of Specification (OOS), Out Of Trend (OOT) and non-conformances.

Manage inventory of panels and batch status through SAP.

Provide support during FDA and TUV inspections.

Execute/review/approve change controls.

Prepare annual product quality review (PQR/APR) report.

Prepare/approve Standard Operating Procedures (SOPs) and other relevant quality related documentation.

Approve equipment qualification protocols and reports.

Review and maintain executed batch records and associated analytical data.

Prepare/approve validation protocols and reports.

Oversee general operations of laboratory, assuring lab supplies inventory and resolve lab issues.

Mentor and guide team members ensuring their qualification and capabilities of performing assigned duties.

Troubleshoot equipment issues and identify the need for new equipment.

Scientist I, Quality Assurance July 2012 to June 2015

Ortho Clinical Diagnostics Raritan, NJ

Performed raw materials, finished products and stability testing using ELISA and immunoelectrophoresis.

Participated and contributed to continuous improvement and problem solving activities.

Contributed on development of work instructions, batch records, equipment logs, material specifications and other device history documents.

Maintained, cleaned and troubleshooted medical equipment malfunctions.

Investigated non-conforming materials and performance issues.

Environmental Health and Safety (EHS) committee member.

Maintained stock levels of laboratory supplies and handled all equipment maintenance and calibration.

Medical Technologist-Serologist I November 2011 to July 2012

Ortho Clinical Diagnostics Raritan, NJ

• Performed Serology testing for in-process products.

• Reviewed, maintained and completed batch records.

• Maintained, cleaned and troubleshooted medical equipment malfunctions.

Arpit Patel

3627, Christopher Day Road, Doylestown, PA 18902 Ph: 732-***-**** ********@*******.***

Cell Processing Associate I October 2010 to September 2011

Dendreon Corporation LLC Morris Plains, NJ

• Performed aseptic cell processing of clinical and commercial human blood therapeutics in a clean-room environment.

• Reviewed executed batch records to ensure compliance.

• Trained team members in clean room behavior, aseptic techniques, cGMP, quality systems and safety requirements.

QC Technologist I September 2009 to October 2010

International Technidyne Corporation Edison, NJ

• Analysis of biological raw materials and finished products.

• Collaborated with cross functional teams to investigate and resolve non-conforming materials and performance issues.

• Performed batch record review and prepare study reports.

Education

Master of Science: Pharmaceutical Chemistry 2015

New Jersey Institute of Technology, Newark NJ

Bachelor of Science: Biotechnology 2009

Rutgers University, New Brunswick NJ

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