OBJECTIVE:

• Highly skilled, team player with over 10 years of GMP Quality Assurance experience in the Biopharma Industry seeking to join a thriving Pharmaceutical/ Biotech Company and make a significant impact on people’s quality of life.

PROFESSIONAL EXPERIENCE

Confidential, Menlo Park, CA

Quality Associate Specialist

Responsibilities:

• Perform review and approval of Lot History Records, Batch Records and Raw Material Inspection Records/Lot Release
• Initiate non - conformities reports (NCMRs) and collaborate with cross-functional teams to thoroughly investigate, document and resolve discrepancies
• Conduct production and facilities walk-through inspections on a monthly basis
• Maintain record-keeping and quality reporting for lot release metrics, batch record review data and production walk-throughs
• Revise company procedures and work instructions as needed
• Participate in audits and audit-related activities
• Knowledge of current federal and state regulations regarding QSR, GMP and ISO

Confidential, Fremont, CA

Quality Assurance Specialist

Responsibilities:

• Reviewed and approved electronic and hard copy GMP batch records, exceptions, test data and associated attachments through SAP, LIMS and the Manufacturing Execution System to verify all documents meet quality standards and approved procedures
• Performed small parts, hoses, equipment and area changeovers with manufacturing/reviewed and approved cleaning batch records, test results, labels, quantity and ensure parts are properly segregated for release
• Received and reviewed Excursion Analysis Reports and trending of data for the Siemens Building Management Systems (BMS) through the RTReport System/confirm reports, point names, alarms and graphs are accurate and consistent for approval and reconciliation on a weekly basis
• Participated in Manufacturing Compliance Area Walk-Throughs which include equipment inspections, confirmation of calibration dates, review of current SOP revisions and overall facility inspection readiness

Confidential

Quality Assurance Associate/ Distribution Specialist

Responsibilities:

• Performed inspections of incoming samples, labels, attached documents, temperature monitors and shipping containers/logged in and segregated GMP and Research and Development samples to designated temperature controlled areas
• Reviewed batch record documentation, sampling sheets, certificates of analysis, Proforma invoices and TempTale data of incoming GMP and R&D materials to comply with company Standard Operating Procedures, Sampling Plans and Material Transfer Request forms
• Received API, Clinical Reserve, QA Reserve, Method Validation, FDA Forensic and GMP Inventory samples in LIMS per GxP Documents and receipt reference procedures, applied GMP LIMS labels and stored materials in proper Quarantine and Release caged areas/non-compliant and customer complaint materials are labeled and stored in Hold and Return areas
• Dispensed and distributed Research and Development, Formulation and Process Development and Analytical Development samples to proper contacts
• Prepared temperature controlled packing containers, temperature monitors, samples and proper documentation in support of outbound shipments
• Initiated deviations in Trackwise, segregated and prepared “on hold” materials and assisted in Quality Assurance deviation investigations
• Participated in Quality Assurance GMP Warehouse Walk-Through audits/report findings and suggest ideas for improvement
• Assisted management with construction of the Quarantine, Release and FDA Cages built in the GMP Warehouse

Confidential

Quality Assurance Associate

Responsibilities:

• Supported Manufacturing, Materials Management and Quality Management System departments
• Performed QC assays/solid product, ash, water conductivity and pouch burst tests
• Sampled chemical products in laminar flow hoods in preparation for outsource testing
• Conducted visual and dimensional inspections of raw materials, in-process materials and chemicals following SOP, GxP and GMP guidelines providing completed documentation for review and release through the EDMS System
• Reviewed and approved inspection documents, released materials in the EDMS System, release sticker and segregated materials from Quarantine areas to Released areas
• Received, inspected, sampled and tested sterile pouch products from outsourced sterilization labs in preparation for additional QC and Microbiology tests
• Verification of batch records before, during and after assembly process of product for Manufacturing and Final Packaging departments/performed line clearance and changeovers
• Inspected final kit box product per sampling plans, stored reference samples, performed reconciliation of remaining materials and rejected materials for disposal to proper containers/verified and approved lot batch record documentation for release of final lot product
• Maintained data and inventory of conformance products, initiated and executed proper forms for non-conformance products
• Initiated minor to major SOP, raw material specifications and documentation revisions/redline and revise electronically
• Managed Quality Assurance inspection area, trained associates on proper Quality Assurance SOP’s and protocols
• Generated deviations in Trackwise and assisted Quality Engineering with customer complaints and investigations
• Assisted Quality Engineering with First Article Inspection testing (FAI)
• Participated in Kaizens, CAPA investigations, FDA and corporate audits
• Specialized skills: Aseptic Technique, Pipetting Technique, thorough knowledge of lab safety procedures/hazardous materials, knowledge of Good Manufacturing Practices (GMP’s), Good Laboratory Practices (GLP’s), Good Documentation Practices (GDP’s), Standard Operating Procedures (SOP’s) and applicable quality and regulatory standards and regulations