SUMMARY:

• me is a registered nurse (RN) wif over 14+ years of experience in Quality Systems/Operations, Complaint Handling, Medical Device Reporting, Authoring Annual Product Reviews, Auditing, Document Management, and various Laboratory skills.
• My experiences include teh Biotechnology, Devices, Pharmaceutical and teh Consumer products industries. Excellent analytical, problem - solving and technical writing skills.
• Served as group lead for over 6 years, offering mentorship and guidance on daily shift activities to team members. Working knowledge of ICH guidelines, GMP, GLP and GCP by following 21 CFR parts 58, 210, 211, 803, 806, 820, 1271 and ISO 9000/9001. Utilized Trackwise, Catsweb, ARGUS, CRTS, SAP, Pilgrim, JDE and Oracle databases

PROFESSIONAL EXPERIENCE:

Confidential, Framingham, MA

QA Clinician

Responsibilities:

• Responsible for authoring, reviewing and revising clinical narratives for serious adverse events (SAEs).
• Provided clinical and quality expertise on teh subject of reporting adverse events to FDA (US), PMDA (Japan), HC (Canada), TGA (Australia) and MDV (EU).
• Assessing for reportabilities in clinical and commercial patients for both domestic and international customer complaints.
• Completed numerous reportability decision forms.
• Assessed complaint investigations and completed FDA coding for MedWatch Reports and Alternative Summary Reporting.
• Remediating past complaint reports to meet expectations set forth by teh FDA form 483.
• Contributed to teh reduction of teh backlog of customer complaints as evidenced by team metrics.

Confidential, Wayne, NJ

Quality Assurance

Responsibilities:

• Responsible for receiving and documenting product events reported by customers and field representatives via teh complaint tracking system Trackwise.
• Request additional information as needed for complete understanding of teh event and assessed events for regulatory reportability and potential impact to patient safety and business operations.
• Managed teh completion and submission of regulatory reports wifin teh timeframes mandated by teh FDA and international regulatory authorities.
• Utilize teh MAUDE database to gather information for report submission.
• Investigated complaints by gathering sufficient data from clinical staff, representatives, internal employees, clinicians, and laboratory analysis.
• Review and modify department procedures as necessary to stay current wif corporate standards.
• Develop internal systems, methods, and procedures to maintain compliance and support post-market surveillance.
• Serve on multi-business teams to evaluate system changes/upgrades.
• Maintain enhanced technical knowledge of devices in area of responsibility.
• Educate and train others on teh proper method of reporting complaints.
• Routinely analyzed and evaluate work and computer processes to improve work processes and service to customers.
• Complete Health Hazard Evaluations and provided clinical feedback for Death/Serious Injuries.

Confidential, Parsippany NJ

Quality Assurance Consultant

Responsibilities:

• Responsible for ensuring compliance of teh third party operations wif teh standards of teh client’s quality manual and any applicable regulations.
• Ensure timely compilation and thorough assessment of teh annual product reviews.
• Managed customer complaints, and ensure closure in a timely manner.
• Worked wif product vigilance to resolve and improve product issues leading to adverse events and complaints involving suspected lack of efficacy.
• Provided Quality support for allocated projects related to quality, operational TEMPeffectiveness, and cGMP compliance.
• Managed multiple products and priorities, follow schedules and meet deadlines.
• Kept record up-to-date.

Confidential, Morris Plains NJ

Senior Quality Assurance Associate

Responsibilities:

• Functioned as a team lead whereby me was responsible for teh disposition of raw materials, packing materials, bulk products and finished goods.
• Extracted patient information (Data collection) from clinical records for phase III clinical trials.
• Reviewing clinical and commercial batch records.
• Supervising and delegating various disposition activities to members of my team in order to advance teh production and delivery of product.
• Recommended quality input when nonconformance occurs in teh manufacturing process.
• Collaborated wif Shop Floor and Scheduling appointees to resolve any issues related to time management which may impact quality of a final product.
• Provided quality oversight in teh shipment of multiple final products.
• Contributed to teh increase in teh closure rate of teh back-log of batch records.
• Streamlined multiple processes by using Lean Manufacturing tools, example Kaizen.
• Using various statistical tools such as Pareto charts and process control charts to demonstrate dat various processes were in control.
• Performed risk analysis for multiple gaps in QA processes (SOPs, best practices, work instructions and ).
• Pulling and performing data analysis from various sources including, inventory management system (Oracle), Excel or deviation management system (Trackwise or Pilgrim).
• Wrote SOPs to address gaps which enabled quality improvement.

Confidential, Edison, NJ

Quality Assurance Auditor III

Responsibilities:

• Assure products meet all criteria prior to release to regulatory agencies and customers.
• Authored investigations, deviation and notice of event reports
• Recommend final disposition of product release in inventory system.
• Identify and follow up wif operations and QA on discrepancies.
• Determine and recommend corrective action.
• Prepare data entry of process metrics for tending and improvement projects.
• Assure dat all records are maintained and archived according to company requirement and SOP’s.
• Cross wif our value stream to assist wif batch record review in times of staff shortage.
• Review and assess change requests and change control for compliance wif company policy.
• Provide guidance on change control policies and procedures to change initiator and management.
• Inform management of compliance issues identified while assessing change requests.
• Conducting audits of quality systems

Confidential

Quality Assurance Manager

Responsibilities:

• Responsible for three direct reports
• Authored, investigations, deviation and complaint investigation reports
• Contacted customers for packaging component, raw material, bulk product/finished goods specifications and Quality Manuals.
• Coordinated all calibrations (scales, thermometers, calipers, torque meters manufacturing equipment and production equipment).
• Approve all packaging Bills of Material (BOM).
• Investigate all Customer Complaints and prepared teh Quality Incident Report for approval.
• Investigate all production Quality Incidents and prepare teh Quality Incident Report for approval.
• Tracking and trending of Quality Incident Reports.
• Completing all regulatory (FDA, ATF, etc.) forms.
• Completing all customer Quality scorecards.
• Wrote multiple standard operating procedures.

Confidential

GLP Quality Assurance Auditor

Responsibilities:

• Auditing reports (in-house and CROs), protocols and protocol amendments in accordance wif GLPs
• Report audit findings, by following departmental SOPs and FDA regulations
• Scheduling closeout meetings via in person and/or conference calls.
• Assure corrective action activities are completed, by generating a QA statement.
• Assisting/coordinating department in teh preparation for IND and FDA inspections
• Preparing regulatory citation database (483, EI reports ect)
• Schedules and performs audits of all teh various phases of non-clinical studies.
• Assists in developing, applying, and monitoring corrective actions.
• Report audit findings to operational and R&D QC management and follow-up on responses.
• Assures critical issues are raised to site QA managers.
• Preparing SOPs concerning teh specific QA activities.
• Interacting wif senior associates and managers on vital matters.
• Auditing records, toxicology, bioanalytical and Pharmacokinetics and formulations report/raw data.

Confidential

Quality Associate

Responsibilities:

• Testing and inspecting work-in-process and finished products according to company SOP
• Generating, reviewing, and circulating SOPs, and other plant documents
• Investigating component and finished product deviations and non-conformances
• Generating, distributing, and maintaining non-conformance reports
• Forwarding samples and collaborating wif Marketing, Research and Development, Consumer
• Affairs and Technical Packaging Department in approvals and release of new product launched
• QA and Production personnel on SOPs, GMPs and Quality Surveillance procedure
• Placing orders for QA lab equipment
• Auditing OTC batch and fill records
• Establishing Quality Surveillance and finished goods inspections in teh Production Department
• Testing finished goods, incoming bulk and raw materials.
• Running, trouble shooting, preparing standards, mobile phases and diluents for HPLC
• Running Alcohols on GC and other wet chemistry techniques.
• Maintaining a laboratory notebook, using in-house LIMS