SUMMARY:

• Quality Assurance and Regulatory Affairs results - and deadline-driven expert with 14 years of experience managing a combination of systems integrations.
• Quality System and Regulatory Affairs regulations in the pharmaceutical, biotech, and medical device industries, fostering close cooperative relationships with critical business units to ensure global regulatory compliance.
• Accomplishments:Executed successful PQ and data HPQC for BMRAM integration project for TFG
• Led successful execution of $500 Million pharma product launch for Teva API
• Improved and maintained critical communication between Quality, Ops, and Supply Chain

PROFESSIONAL EXPERIENCE

Confidential, Tarrytown, NY

Quality Assurance Documentation

Responsibilities:

• Conduct product quality complaint investigations involving consumer complaints and adverse events for OTC, Medical Device, Cosmetic, and Household products
• Coordinate the documentation related to complaints and adverse events in compliance with cGMPs and associated SOPs
• Work with external partners to facilitate investigations
• Complete trend reports to meet departmental metrics measurements
• Participate in data analysis to identify trends

Confidential ., Woodcliff Lake, NJ

Regulatory Affairs Associate

Responsibilities:

• Evaluated non-conforming product and drove organizational decision on product field actions
• Managed and maintained manual Quality System, Change Control lifecycle, and all aspects of data flow within Non-Steriles Regulatory Affairs (PAS, CBE-30, CBE-0, ARs)
• Discretion of highly sensitive business processes and decisions, supporting Director, Regulatory Affairs, in implementation and maintenance of process improvement initiatives
• Executed periodic audits to high visibility Regulatory spreadsheets for review by and distribution to Executive Management, within required timelines
• Assist with specific CMC project activities including preparation of supplements and Annual Reports for parenteral drugs
• Ensure the Quality (CMC) section of the submission documents is complete and consistent with applicable regulatory guidelines (GDUFA, ICH, SOPs) and requirements
• Assess change controls and collaborate with management to determine the types of Regulatory submissions required such as CBE, CBE-30, annual reportable, etc.

Confidential, Mahwah, NJ

Sr. Quality Engineer

Responsibilities:

• Review reports of customer complaints and assess for MDR/MDV reportability to FDA/Competent Authorities within required timelines
• Submit initial and follow-up regulatory reports to device related Agencies as appropriate
• Interact with device related Agencies on vigilance reports and incidents
• Request information from the field to ensure all pertinent information is acquired to make adequate MDR/MDV decision
• Review medical assessments and manufacturing investigations to include in regulatory reports
• Review and analyze data for trending

Confidential

Quality Reviewer II

Responsibilities:

• Manage approval process for rapid decision making and action
• Perform intake of clinical product complaints from clinical sites
• Review and liaise with Clinical Site personnel all incoming complaint data and investigations
• Escalate all critical complaints
• Perform complaint data trending and analysis
• Collaborate with complaint investigators on clinical complaint investigations revisions/updates
• Oversee maintenance of heavily regulated clinical documentation, per ICH guidelines
• Support investigation and change management quality systems

Confidential, Wayne, NJ

Senior Product Analyst - Complaints Manager

Responsibilities:

• Evaluated potential non-conforming product and drove organizational decision on product field actions
• Managed approval process for rapid decision making and action
• Managed all aspects of Cardiac Surgery medical device complaints, including investigation, responses, root cause analysis, CAPA, and final review/closeout
• Investigation and documentation of field clinical events and follow-through
• Authored and submitted MDRs and MDVs to FDA
• Performed periodic audits on complaint data, per company & regulatory requirements
• Identified and assessed new opportunities for improvements to work processes and practices
• Executed all aspects of complaints metrics - data analysis, organization and presentation
• Managed all complaints-related Quality and Regulatory documentation

Confidential

QA Product Complaints Specialist/TrackWise Administrator

Responsibilities:

• Managed approval process for rapid decision making and action
• Managed all aspects of prescription drug products and medical devices complaints, including investigation, responses, and closeout
• Maintained and updated TrackWise database and hard copy files for tracking
• Collaborated with medical and regulatory professionals to arrange product/batch investigations of adverse events and medical device malfunctions
• Collaborated with Senior Management on revisions of policies and procedures, including Business Continuity Plan, Disaster Recovery, Complaint Audit procedure
• Maintained discretion of highly sensitive business information and confidential materials
• Created process flow maps using Visio to write/revise departmental procedures
• Executed validation protocols for complaints handling database
• Troubleshoot database issues, identify root causes, and implement optimal solutions
• Created and implemented Complaints Audit Plan
• Reviewed manufacturing and packaging investigations of complaints reported

Confidential, W Paterson, NJ

Quality Assurance Specialist II (Purdue Pharma)

Responsibilities:

• Coordinated all facets of Third Party Supplier complaint investigations lifecycles
• TEMPEffected changes to product complaint investigations and Root Cause Analysis in collaboration with Senior Management
• Managed all aspects of Stability Data from Third Party Suppliers
• Executed cGMP documentation control of Third Party Supplier complaint investigations, stability reports, and all paper-based and electronic versions of Annual Product Reviews (APRs) from Third Party Suppliers

Confidential,Ramsey, NJ

Documentation Development Specialist Manager

Responsibilities:

• Manage approval process for rapid decision making and action
• Spearheaded a Documentation Control Department to control all aspects of cGMP documentation, including identifying and developing an action plan to improve paper-based documentation structure
• Interacted with technical personnel to address issues and requirements, i.e. IQ/OQ/PQ documents and validation of equipment, facility commissioning documents, process deviations in manufacturing, internal manufacturing investigations, calibration deviations, cleaning and process validation protocols, and change controls
• Represented Glatt during routine DEA and FDA activities/audits and client audits
• Performed routine audits on manual documentation systems
• Wrote, revised, researched, analyzed and interpreted policies and procedures, including Military Standard Specifications Procedure and Handling FDA Audits, Company Motto, and Company Dress Policy

Confidential, Pearl River, NY

QA Compliance Documentation Specialist

Responsibilities:

• Promoted from Consultant to Permanent Employee in February 2004
• Managed strategic application qualification efforts from project inception through go-live, including test methods, validation protocols, and procedures
• Collaborated with lab experts on SOP revisions
• Directed Quality Compliance inter-departmental meetings utilizing corporate compliance presentations and communicated compliance-related concerns to various Quality departments
• Evaluated Laboratory documents to meet domestic and international requirements
• Audited, maintained, and archived all laboratory and batch record documentation
• Attended internal laboratory supervisors/managers meetings to review documents