- FDA regulations.
- Microsoft Office
- LOTUS Notes.
- Fiber Optic
- Atomic Absorption.
Sr. QA Compliance
Confidential - Piscataway, NJ
- 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.
Confidential - Fair Lawn, NJ
- 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
- 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.
- 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.
- 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.