SUMMARY

• Strong background in Quality Assurance, Compliance, Project Coordination, Data Integrity, 21 CFR Part 11, CFR Part 820, CFR Part 210 and CFR Part 211.
• A highly - motivated QA specialist and project coordinator skilled in the organization and management of cGMP pharmaceutical environment.
• Hands on experience on GMP systems like - Veeva Vault, Trackwise, Oracle Database, CRMS ( Corporate Records Management System), Integrated Quality System (IQS), Documentum, GBAS, GPLM, GForce, Share point and Electronic Quality Management System (EQMS).
• Experience in review and approval of Change Controls, CAPA (Corrective and Preventive Actions) and Deviations.
• Record and Archive the executed and approved documents in the Document Archival Room.
• Ability to compose reports, document procedures and revise procedures.
• Ability to prepare and track Excel spreadsheet reports, document upload and scan on the system.
• Interact with document author and reviewers to coordinate documents draft, review and approval on the Document management System.
• Ability to be flexible and manage changing priorities.

TECHNICAL SKILLS

Computer Proficiency: Adobe PDF, Microsoft Word, Visio, Excel, Power Point, and Project.

Management: Team worker, good time management, problem solving skills and strong organizational skills.

PROFESSIONAL EXPERIENCE

QA Specialist

Confidential, Foster City, CA

Responsibilities:

• Review clinical manufacturing, packaging, and labeling drug product batch records, in-process quality control data.
• Compile and reconcile data from multiple databases (IQS, GVault, Trackwise, GBAS, etc.) to create Monthly and Quarterly Quality Management Review (QMR) Metrics.
• Responsible for Clinical Change Management - document number assignment, request assessment from different departments, scan and update database.
• Coordinate CPV Report Review Project with key stakeholders such as Formulation and Development, Clinical Packaging & Labeling, Clinical Supplies Management, and Regulatory Affairs as needed to facilitate product release.
• Schedule, lead and follow up with Process engineers, Functional Area Managers, QA and Senior Leadership to coordinate weekly and monthly review meetings for Annual Product Quality reports
• Assist in creating eTMF (Electronic Trial Master File) process within PDM Clinical QA, while maintaining, archiving and ensuring change control of TMS remediation artifacts.
• Reviewing and approving Change Control, CAPA and Deviations for GMP Computerized Systems.
• Maintain programs and processes to ensure high quality products and compliance with cGMP (current Good Manufacturing Practice) and GLP (Good Laboratory Practices).
• Created work instructions for Clinical Change Management record archival process on GDocs, Manual archiving of Electrical Batch Records (EBR), CoA (Certificate of Analysis), CoC (Certificate of Compliance) and deviation reports.
• Responsible for archiving large number of Clinical documents using CRMS system.
• Maintain electronic records in Trackwise, Oracle Enterprise Business Suite (EBS), Electronic Batch Review Systems, Veeva Vault, etc., and paper archives as needed.

QA Specialist

Confidential, Hayward, CA

Responsibilities:

• Reviewing and approving Change Control, CAPA and Deviation records to support QA review and approval.
• Responsible for managing executed document archival on Company Document Archival Repository.
• Ensuring documents submitted to the document control system are approved in a timely manner and meet formatting and content requirements.
• Scanned and created Optical Character Recognition (OCR) via Adobe Acrobat for executed protocols, Change Requests and executed Log Books.
• Work with Subject Matter Experts (SME), Area Managers and QA Personnel to properly convert documentation into final written form and ensuring the appropriate document approvals are obtained prior to documentation becoming effective.
• Actively supported FDA Audit and provided all documents requested from auditors in urgent manner.
• Perform routine document control activities - document creation, revision, review and approval, log book issuance, Excel spreadsheet preparation and tracking.
• Organize and update documents as necessary to maintain compliance on GMP documents such as batch records, logbooks and validation documents.
• Maintain related database systems, logs and archive completed forms/records/executed protocols as required.
• Ensuring cGMP and company procedure compliance for all types of GMP documentation.
• Assist in implementing QA policies and procedures and adhere to written policies and procedures when performing daily tasks.

QA Document Specialist

Confidential, Parsippany, NJ

Responsibilities:

• Responsible for routing GMP validation documents like Standard Operating Procedures, Requirement Specifications, Qualification Protocols, Work Instructions, Validation Summary Reports and Traceability Matrices on Electronic Document Management System (EDMS).
• Perform document control activities on Veeva Vault system for documents from different departments - Validation, Clinical, Quality Control, Facility, Maintenance etc.
• Identify metadata for documents - Name, Title, Type, Sub Type, Share Settings and References.
• Assist in document revision control and change route.
• Facilitate and coordinate users with posting effective SOPs and applying training requirements.
• Ensuring documents remain legible, readily identifiable and retrievable from the system.
• Assist to track documents from Electronic Document Management System and archival room during internal and external audits of Document Control.
• Comply with company’s document control standards, policies and procedures
• Maintain and provide status update for GMP training requirement to users.
• Assist in scanning and uploading executed documents on EDMS or Archival Room.
• Track in process routing documents and provide weekly status update to the document authors, reviewers and approvers.
• Maintain document database (obsolete and current) and assisting users with creating new document or to revise existing effective documents.

QA Documentation Specialist (Internship)

Confidential

Responsibilities:

• Routing validation and IT documents for Draft, Review and Approval cycle on the Company’s Document Management System.
• Reviewing document format as per standard approved template requirement.
• Assisting users in document format correction and document review and approval.
• Processing document execution requests and providing approved executable copies.
• Archiving the executed and approved documents in the document archival control unit.
• Store and manage documents in the archival room as per standard operating procedure.
• Processing document change request, document revision, review and approval.
• Assigning document owner, reviewers and approvers on the system.
• Maintain data integrity of the GMP documents as per Good Documentation Practices.