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Sr. Qa Compliance Resume

Piscataway, NJ

TECHNICAL SKILLS

  • cGMP
  • FDA regulations.
  • Microsoft Office
  • SAP
  • LOTUS Notes.
  • IHPLC
  • Fiber Optic
  • UV/VIS
  • FTIR
  • KF
  • Atomic Absorption.

PROFESSIONAL EXPERIENCE

Sr. QA Compliance

Confidential - Piscataway, NJ

Responsibilities:

  • Coordinated and organized the Quality Compliance function.
  • Ensured all departments understand and comply with cGMP, applicable regulatory requirements (FDA, U.S., EU, and international). As needed provide relevant training and support.
  • Management of (CAPA) and Change Control Review processes, and Customer Complaint Systems.
  • Reviewed process changes and deviations affecting manufacturing protocols.
  • Reviewed and approved Quality Systems Records, Reports and SOP’s.
  • Evaluated and reported on Customer Complaints, Medical Device Reports (MDR.), involving the complaint resolution/CAPA teams.
  • Processed complaints requiring Customer Notification/Field Corrective Action and/or Product Recall.
  • Applied quality tools for Bid review, ensure compliance or recommend options.
  • Strong interaction with suppliers and redesign of process maps.

QA Engineer

Confidential - Fair Lawn, NJ

Responsibilities:

  • Managed QC lab operations.
  • Supported Research projects in laboratory operations aspects.
  • Handled and analyzed customer complaints, developed metrics, trends, and drive them to resolution.
  • Followed up, generated reports and issue response letters to medical offices.
  • Identified Quality/Compliance issues related to CAPA and complaints.
  • Initiated change requests related to CAPA or process improvements.
  • Tracked quality commitments from Internal/ External Audits, Investigations and CAPA.
  • Supported the GMP and GCP programs for product and process development.
  • Reviewed and approved Quality Systems records, protocols, reports and SOP’s.
  • Developed and validated test methods and procedures.
  • Participated in clinical studies, managed and evaluated case studies and progress reports with results.
  • Supported FDA inspections and FDA-483 resolutions.
  • Supported product and process improvement program as well as product stability projects.
  • Supported Drug Delivery technology projects on combination products (Drug & Medical Device).

Sr. Quality Assurance

Confidential, NJ

Responsibilities:

  • Provided support with product and process investigations and data analysis, as requested by Quality management.
  • Performed final review of drug product batch records to ensure conformance to cGMP.
  • Performed final review of QC laboratory test and QA Incoming inspection report for compliance to internal standards and cGMP.
  • Reviewed Customer Complaints and Investigations.
  • Reviewed and approve CAPAs and perform CAPA verifications.
  • Monitored responses to previous internal audits and action plans including CAPA items.
  • Developed audit scope and coordinate audit activities. Conducted meetings to discuss observations found during the audit, and issue an audit report.
  • Conducted internal systems audits for cGMP compliance according to established schedule and procedures.
  • Conducted direct compliance audits and follow-ups, consisting of Corporate Compliance Audits, Mock Audits, and External Audits of P.F. Laboratories, Inc.
  • Reviewed and verified current status of all 2003 and 2004 FDA 483 Commitments.

QC Supervisor

Confidential, NJ

Responsibilities:

  • Coordinated all operations associated with release and stability testing of finished products including laboratory testing, data review and QC approval of results to ensure turnaround time.
  • Coordinated/ ensured that all contract laboratories meet the QC laboratories standards.
  • Conducted OOS result investigations and deviations and initiated CAPA.
  • Conducted meetings and ensured compliance with cGMPs, DEA and OSHA regulations and SOPs.
  • Participated in regulatory inspections FDA, EMA, DEA and internal/external audits for new product launch.
  • Ensured equipment is maintained and calibrated and monitored service of instruments used in department.
  • Coordinated data audits of validation reports (i.e. IQ, OQ, PQ) as needed.
  • Coordinated Product Compliance Assessment and Gap Analysis (i.e. equipment qualification, calibration status, and analytical data review, etc.)
  • Scheduled department staff and trained new laboratory staff.

Chemist

Confidential, NJ

Responsibilities:

  • Responsible for analytical testing of stability, finished products, and raw materials.
  • Performed analytical tests on an ongoing basis - Assay, CU, Dissolution, and Impurities Tests.
  • Responsible for testing Validation Batches, Cleaning Validation, and Method Transfer.
  • Performed all raw materials testing using USP/NF.
  • Trained other analysts on the Waters Millennium 3.2 v, Fiber Optic.
  • Instrumentation used: HPLC, Karl Fisher, T.L.C., UV / VIS,FTIR, Atomic Emission Spectrometry.

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