SUMMARY:

• An experienced Regulatory Compliance Specialist/ Quality Assurance/ Auditor, and a Clinical Research Associate with 10+ years of pharmaceutical and medical device industry experience.
• Demonstrated ability to improve productivity as an adaptive accomplished, and motivated Quality Assurance Compliance Specialist. Skilled in GCP compliance, working knowledge of 21 CFR’s and ICH guidelines.
• Strong organizational and communication skills used to positively influence company operation, performance, and profitability. Skilled in GMP, GLP, GCP compliance and FDA regulations.
• Seeking a position where I can utilize my skills, grow and develop my career and contribute to the success of the drug and medical device development process.
• FDA Remediation expertise
• EDC experience: Inform, Rave
• CTMS experience: Impact Harmony
• Computer proficiency; Microsoft Office suite, EPIQ, SAP, IBM Maximo, AS400, Visio, Lotus Notes.
• Experience with call related programs; Verint, Mattersight, Avaya
• Ability to maintain good communication and work relationships within teams.
• Excellent organizational skills with a keen focus on accuracy and deliverables
• Strong analytical and logical problem solving skills.

WORK EXPERIENCE:

Confidential

Post Market Quality Engineer

Responsibilities:

• Conducting remediation for medical equipment in an ISO 13485, 21 CFR 820, and cGMP environment.
• Developing Design / Design History Files and ensuring they are maintained in a manner consistent with FDA (Food and Drug Administration) requirement
• Maintaining Device History File(DHF), Device History Record(DHR), Device Master Record(DMR) and updating records
• Led reduction in time to closure for timeliness of nonconformance, CAPA, and Supplier Corrective Action Requests (SCAR).Identifying applicable corrective and preventative actions (CAPA) to facilitate complaint closure
• Performing queries to provide complaint data and trend analysis on reported product / complaints
• Reviewing (NCR) non - conformance/deviation investigations and initiating corrective and preventive actions (CAPA) and /or Quality Investigations. Ensuring appropriate failure mode classifications are assigned to allow precise trending for data analysis purposes
• Working with R&D to determine specific product and incident complaint codes.
• Coordinated and executed internal and external audit support including ISO13485:2003. Executed FDA 483 Response closure within the established timeline.
• Striving to meet accuracy goals (95% ) by ensuring data is collected through routine business processes and is reviewed for accuracy, timeliness, relevance, completeness, understood by users and quality.
• Coordinating adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion
• Reviewing code reports and helping out with RGD Data Scrubbing

Confidential

Post Market Surveillance Analyst

Responsibilities:

• Coordinating activities related to QualityAssurance, Supplier Corrective Action Reporting (SCARs), Complaints, Material Review/Non-Conforming Material Reports (MRRs/NCRs), Medical Device Reporting (MDRs), and Product Inquiry Reports
• Performing a gap analysis against 21CFR-820 and ISO-13485 requirements for qualification of attribute and variable test methods, and then conducted remediation activities to close the gaps through revalidation and other corrective actions.
• Working closely with Design Engineering and suppliers to ensure successful new product launches for Class I, II and III devices.
• Supporting development and updating of PFMEA and related risk assessment documentation.
• Working with cross-functional teams in developing a Risk Management Plan and DFMEA.
• Managing and maintained adverse event files and Medical Device Report (MDR) tables
• Creating, organizing and managing regulatory files and documentation including FDA submissions, International submissions, annual and ad hoc reports
• Identifying applicable corrective and preventative actions (CAPA) to facilitate complaint closure
• Screening all complaints, both domestic and international to identify events requiring submission to the FDA and/or other International regulatory agencies
• Ensuring appropriate failure mode classifications are assigned to allow precise trending for data analysis purposes
• Authoring reports based on findings obtained from complaint investigations
• Maintaining strict confidentiality while handling details of a highly confidential and critical nature.
• Coordinating adverse event investigations with co-workers and other departments to ensure compliance with regulatory timelines for completion

Confidential

Clinical Research Assistant

Responsibilities:

• Responsible for coordinating and verification of all in-house documents generated by study sites, monitors and other related sources involved in clinical research projects
• Reviewing of study and research documents for completeness and accuracy
• Serving as a point of contact for field based monitors and study sites
• Tracking of study documents and maintaining accurate entry of data
• Assisting in the planning and organizing of investigator meetings and s
• Proactively identifying study related issues that arise from time to time and providing recommendations for resolution
• In-house tracking of activities at study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOP), FDA regulations and all study protocols
• Collecting, reviewing and processing regulatory documents from investigator sites
• Participating in project team meetings
• Preparing all site documents and visit reports for filing in the Trial Master File
• Assisting in other areas of clinical study projects as may be assigned.