Quality Assurance SPECIALIST Resume New Haven, CT – Hire IT People – We get IT done

SUMMARY:

Quality Assurance Professional with extensive medical device experience working in FDA regulated companies. Expertise in CFR 21 820, IS0 13485, Corrective and Preventative Action ( Confidential ), Training and Validation. Implemented SAP ERP system WM, MM, SD and FICO, Certified Quality Auditor (ASQ – CQA). Member of Validation Project Management teams.

PROFESSIONAL EXPERIENCE:

Confidential, New Haven, CT

Quality Assurance SPECIALIST

Responsibilities:

• Assist in daily activities for the ongoing development and operations of the GMP and GLP Archive with Quality Assurance.
• Lead in carrying out the operational requirements that result from policies, procedures, regulations, and guidance documents governing the management of records that exist in print and electronic form.
• Manage record retention schedules, outreach to other internal/external archival support staff, and the acquisition of GMP Archive records.
• Coordinate documents such as laboratory notebooks, binders, procedures, photographs, computer printouts, protocols, technical reports, resumes, audits, facility records, validation documents, and certificates of analysis (COA).
• Contribute to the completion of milestones associated with specific projects and supports quality systems related to document reviews, training, change control, deviations, corrective actions/preventative actions, and investigations.
• Expedient retrieval of organized and complete records for internal requests, agency requests, and regulatory inspections is a key element to this position.
• Review documents for compliance to regulations, guidances, and internal procedures/policies.

Quality Assurance SPECIALIST

Confidential

Responsibilities:

• Administrator of SAP learning solutions training program.
• Team member responsible for data migration of legacy data into SumTotal Learning Management System.
• Daily responsibilities include training administration and managing outsourced work.
• Review and approve associated training documentation in Documentum Document Management System.
• Provide monthly training metrics.
• Work to close on assigned training deviations and Confidential ’s in TrackWise.

Confidential, Brookfield, CT

Business Process Engineering Specialist

Responsibilities:

• Analyze existing calibration and maintenance methods to standardize, improve and simplify the process.
• Assists in recommending business processes that ensure alignment with strategic direction; integrate business processes between multiple Siemens organizations.
• Documented and coordinated business process changes to assist in implementing a global calibration system solutions using CERDAAC software.

Confidential, Stamford, CT

Quality Assurance Manager

Responsibilities:

• RA/QA member on the Quality Review Board, responsible for approving and closing all Confidential documentation.
• Responsible for review and approval of Quality System Software validation documentation and applications.
• Managed the Complaint Confidential Specialist.
• RA/QA member assigned to implement Astea Alliance Service Management Software system.
• One year reassignment to represent RA/QA at a subject matter expert in the implementation of SAP.
• Supported the Confidential system and backup support for the Document Control System.
• Provided new employee Regulatory and Quality Systems training.

Complaint Specialist

Confidential

Responsibilities:

• Implemented a Part 11 electronic record and signature Document Control and Confidential system.
• Reviewed and finalized all Confidential documentation in preparation for approval by the Quality Review Board.
• Supported the Confidential System, including updates to the software.
• Prepared monthly Confidential metrics reports.
• Reviewed and approved Quality System Documentation.
• Trained and supervised several contractors, which were hired to reduce an existing Confidential documentation backlog.
• Obtained ASQ CQA certification

Confidential, Shelton, CT

Business Development Analyst

Responsibilities:

• Developed monthly reports using Microsoft Access and Excel for upper-level management to track and develop the Service Marketing business.
• Proactively managed the Intranet site.
• Assisted with process and IT development to improve service delivery.

Junior Engineer

Confidential

Responsibilities:

• Obtained Confidential Certification for the reloading of x-ray tubes.
• Developed, installed and supported a corporate-wide inventory RF bar-code system
• Assisted in the automation of the Returns Department using Paradox database software application.
• Involved in the initial installation of departmental LAN and support of all its users.
• Upgraded and repaired LAN workstations and troubleshoot software problems.
• Installed, maintained and upgraded all software packages running on the department server.
• Provided backup support for the Service Department LAN System Administrator.
• Led the Service Repair Department quality team.

Consultant

Confidential

Responsibilities:

• Designed test fixtures, set up test equipment to test Confidential tube.
• Created acceptance test procedures and data sheets to ensure good manufacturing practices.
• Trained service technicians and manufacturing assemblers in testing methods.
• Generated an annual report to submit to the FDA for products that were manufactured in Shelton.

Quality Assurance Specialist

Confidential

Responsibilities:

• Evaluated, tested, and qualified a computerized imaging network for introduction to the market.
• Served as a member of the engineering team responsible for the successful transfer of a computerized converter processing x-ray generator previously manufactured in Germany.
• Solved technical problems in the manufacturing and testing process.
• Established Accepted Test Procedures ensuring uniform testing and adherence to government regulations.
• Evaluated and tested products for conformity to published standards which allowed for installation in hospitals.
• As Incoming Inspection Foreman, supervised a department of eight, made decisions on the processing of materials and processed associated paperwork.