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.

PROFESSIONAL EXPERIENCE

Confidential

Subject Matter expert

Responsibilities:

• Knowledge of Confidential and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, Canadian MDR.
• Subject Matter expert/Super User at site for assigned quality system
• Guide the successful completion of major programs and function in a project leadership role
• Develop training content and provide quality systems training at unit and Plant locations
• Managing external regulatory audits
• Accountable for support of the deployment of an integrated Quality System across MPS
• Support and provide guidance to sites affected by integration efforts for both CAPA content and Trackwise software utilization - Calibration (Blue Mountain RAM)
• Drove the implementation of standardized quality systems processes, as well as facilitate the implementation of enterprise level software solutions for CAPA and Calibration processes
• Maintain and improve the Franklin Lakes and WW Quality System documentation
• Consistent application of Quality system standards to assigned Quality system area
• Working Knowledge of Quality Systems Regulatory requirements and application to Company/Unit requirements

Confidential

Specialized Technical Consultant

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 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

Subject Matter expert

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

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

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

Senior Product Analyst

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

Quality Assurance Specialist

Responsibilities:

• Coordinated all facets of Third Party Supplier complaint investigations lifecycles
• Effected 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

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

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