QA Specialist

Hina Patel, Fremont, CA

******@*******.*** 510-***-**** (H)

PROFESSIONAL EXPERIENCE

Over 10 years experience as a QA Specialist in the medical device, pharmaceutical and biotech industries. Has an ability to prioritize multiple projects, excelled at issuing, assigning and coordinating CAPAs including managing all associated documentation and the facilitation and investigation to determine root cause. Has in-depth knowledge of auditing, document control, CMO management, training and documentation management systems.

INDUSTRY / PROJECT EXPERIENCE

QA Specialist, Carl Zeiss Meditec, CA – 1/08-2/11

• Reviewed internal and external Audit Non conformance findings and CAPA request on real issues.

• Supported complaint review process, and assisted with failure investigation report summaries.

• Reviewed lot history records as needed. Supported departmental audit activities and assisted with complaint closures and linkages.

• Communicated assignments to Audit Non Conformance and CAPA owners and follow-up routinely on investigation status.

• Coordinated and conducted meetings with owners to ensure effective Corrective and Preventive actions are completed as required.

• Monitored CAPA activities to ensure implementation plans/results are thoroughly documented.

• Reviewed and verified evidence of supporting documents to manage the timely closure of Non conformance and CAPA from the Internal or External Audit.

• Performed desktop and spot audit to verify the effectivity of implemented corrective actions.

• Managed CAPA log/metrics and provided an update to management to escalate the process and closure in timely manner.

• Interacted effectively with peers and leadership across departments. Supported an environment of changing priorities.

• Managed Product Hold /Release process in SAP.

• Performed PQ validation for electronic Lot History Records.

• Performed PQ Validations for deviation process.

• Performed other relevant tasks as assigned.

• Provided training as required.

QA Specialist, Nektar Therapeutics, CA – 11/05-1/08

• Reviewed Operations and Contract Manufacturing Organization (CMO) documentation to ensure GLP/cGMP compliance and specifications. Reviewed batch record to support release of raw materials, work in progress and final products.

• Reviewed of records and documents, for completeness and compliance with QSR and ISO requirements.

• Resolved all outstanding issues discovered during the review of documentation in a timely manner.

• Reviewed in-process batch records for compliance with approved SOPs and GLP/cGMP.

• Communicated with Operations and Contract Manufacturing Organizations to ensure overall completeness of documentation to facilitate efficient product disposition.

• Developed and tracked quality metrics related to the contract and internal manufacturing sites.

• Analyzed and evaluated common errors found during the document review and report and resolve to manufacturing and QA management in a timely manner.

• Participated in batch record development to ensure adequate documentation of manufacturing activities while providing a document that is succinct and easily understood by users.

• Investigated and evaluated Exceptions Reports or NCRs from procedure as they affect production and testing activities and determine adequacy of reporting and the potential impact on products.

• Worked with Contract Manufacturer on daily bases to provide technical and logistical support to resolve of problems or issues received from them with regards to the BPR review.

• Participated, and played an active role to support Operation, and CM Process Improvement Projects.

• Reviewed and revised SOPs as required.

• Utilized document control system for inputting and tracking cGMP documents and ensures accuracy of the documents.

• Escalated information appropriately to QA management.

• Provided support to other projects as assigned.

• Trained new employees.

Quality Assurance Consultant, CA – 3/03-6/05

• Reviewed, revised, and maintained validation protocols and SOPs of an Electronic Document System.

• Edited and routed controlled documents for approval.

• Created and maintained training files.

• Implemented document control system compliance to FDA regulation using PILGRIM

System (Electronic Quality Management System/Electronic Storage for Quality Records).

• Evaluated and run the Document Control, Training and Audit Survey module Test Plans using PILGRIM System.

• Reviewed and executed the validation protocols. Wrote and routed validation reports for an approval using PILGRIM System.

• Reviewed, revised and maintained DHF.

• Prepared Technical files for the New Medical Devices and updated as needed.

• Coordinated and Communicated with Core Team Members, Leader, and contract manufacturing sites for the project updates.

• Run and verified different languages Test Plan for the Medical Device.

QA Associate/Document Reviewer, Dade Behring (formerly Syva Company), CA – 1991-2003

QA Associate / Document Reviewer (Quality Services Final Test and Chemical Analysis Group)

• Performed GMP and technical review of manufacturing, intermediate and final products Device History Records including batch production documents, standard operating procedures, and in-process test results.

• Reviewed in-process batch records for compliance with approved SOPs and GLP/cGMP.

• Reviewed all analytical test data and vendor’s data for lot release of final bulk product.

• Resolved all outstanding issues discovered during the review of GLP/cGMP documentation in a timely manner.

• Issued and reviewed Non Conformance Reports to ensure compliance.

• Assisted in discrepancy investigations.

• Worked with other departments to clarify and correct documentation to ensure compliance.

• Contributed to document revision process based on review observations.

• Evaluated and released incoming raw materials according to procedure and specifications.

• Performed final testing of finished products, and completed specification reports in GMP/GLP/QSR/ISO regulated environment.

• Performed stability studies to extend product dating.

• Analyzed and evaluated test data.

• Trained new employees.

Research Associate, Cadila Laboratories Ltd., India – 1982-1991

• Scaled up a fermentation process for steroid biotransformation using bacterial strain

• Acquired knowledge of fermenters

Key Skills

• CAPA/Complaint Review • Document Control • Auditing

• Training • Stability Studies • CMO Management

• Root Cause Analysis • Validation Reports • DHF

• Documentum • Agile System • PILGRIM System

• GMP/GLP • QSR • ISO 13485/FDA 21 CFR

• MS Word, Excel, Office • SAP • CRM

SKILLS:

• Interactive, team player, self-initiating, flexible, and organized and can prioritize multiple projects.

• Ability to establish and maintain effective working relationships with individuals at all levels within and outside the organization, and to communicate effectively verbally and in writing.

• Ability to function in a complex multi-location environment; self-initiating and flexible.

Education:

• Bachelor of Science, Microbiology, Gujarat University, India

References:

• Available on request.

Contact this candidate