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.
