Quality Assurance Engineer
Resume:
Susan Mantia
Email: *********@********.***
Address: **** ******** *****
City: Munhall
State: PA
Zip: 15120
Country: USA
Phone: 412-***-****
Skill Level: Management
Salary Range: $80,000
Willing to Relocate
Primary Skills/Experience:
See Resume
Educational Background:
See Resume
Job History / Details:
SUSAN C. MANTIA
4430 Woodhill Drive Home Munhall, Pennsylvania 15120
412. 977.0210 *********@********.***
QUALITY ASSURANCE
Pro-active, success-driven and highly motivated Quality Professional, with demonstrated success at developing, implementing, maintaining, and improving quality management systems to increase overall organizational performance and ensure compliance with all applicable regulatory requirements. Particularly skilled at leading teams/projects related to complaint investigation, supplier nonconformance investigation, CAPA and quality system excellence, requiring identification, development and implementation of new methods of quality management and systems. Collaborative leader - accomplished at establishing an environment that empowers staff, promotes accountability, and encourages participation and teamwork.
Quality Assurance / Testing Quality Control Policy Development Process Improvement Project Management
OSHA / Regulatory Compliance Audits Identification / Monitoring of Process Indicators
Operations Management Start Ups / Turnarounds Technical Writing Technical Support Customer Service
Training / Development Team Leadership / Motivation Staff Education Distribution Vendor Relations
PROFESSIONAL EXPERIENCE
DIAMYD, INC., Pittsburgh, Pennsylvania 10/2011 - 07/2012
Quality Assurance Director
Directed initial development and implementation of quality system to meet all applicable organizational and regulatory requirements. Created procedures; implemented initial equipment calibration system; and trained staff on its use. Collaborated with contract manufacturing and testing firms to resolve issues identified during audits.
Accomplishments:
* Created and/or revised 10-15 laboratory SOPs to ensure proper documentation of current processes. Efforts enabled laboratory staff to initially follow documented processes during product development, which could then be revised for use by Contract Manufacturing Organizations as applicable during manufacturing technology transfer.
* Drafted ~5 system level procedures to describe upper level processes, including internal auditing, CAPA, employee training, etc. Activities resulted in greater organization of higher level procedures, allowing quality system to become a whole and cohesive infrastructure.
* Led cGMP review of batch records provided by Contract Manufacturing and Testing Organizations for drug candidate's production and testing. Reviewed documentation to ensure completeness and accuracy of information, and interacted with vendor to correct mistakes, thus meeting FDA and potential collaboration partner`s due diligence requirements.
REDPATH INTEGRATED PATHOLOGY, INC., Pittsburgh, Pennsylvania 10/2007 - 08/2011
Quality Assurance Director
Focusing on improving laboratory`s existing quality system, with goal to expand scope to include other departments, revised all administrative procedures to reflect current processes; developed, monitored, and presented reports on yearly quality metrics; initiated CAPA for any identified trends; and created training systems for new pathologists. Prepared all laboratory regulatory documentation for annual renewal and changes; maintained manual document control system; managed all internal and external laboratory proficiency testing programs; and interfaced with IT software development group to create documents for software releases. Performed quality checks on client final reports to ensure correct integration of all required elements. Participated in all regulatory audits, according to New York state licensure and College of American Pathologist accreditation requirements, and managed any resulting CAPA projects. Maintained all laboratory CAPA documentation and included issues in quality metrics.
Accomplishments:
* Achieved New York State licensure, resulting in a 25% increase in client accessibility.
* Evaluated and improved existing laboratory procedures to include required elements, and guided laboratory staff to take ownership of procedures. Laboratory procedures became more streamlined, were written and approved prior to implementation of processes, and had buy-in from all stakeholders.
* Trained Laboratory Supervisor to take ownership of staff training and competency assessment program and internal laboratory proficiency testing program. Furthered Supervisor`s career development and enabled QA Director to focus on other quality system priorities and initiatives requiring implementation and improvement.
* Collaborated with VP, Technical Operations and software development team to create sample release documentation, resulting in better organized release and approval processes required by federal CLIA 1988 and College of American Pathology accreditation requirements.
SUSAN C. MANTIA Page 2 *********@********.***
BODYMEDIA INC., Pittsburgh, Pennsylvania 05/2007 - 10/2007
Quality Assurance Specialist
Reviewed and revised existing quality system administrative procedures to better comply with ISO 13485:2003. Assisted in roll out of new design control process, and served as QA representative in design review meetings. Maintained internal document control system and monitored performance of outsourced manufacturing organizations. Interfaced with test laboratories to ensure biocompatible materials; reviewed customer complaints; and directed CAPA efforts when trends were identified.
Accomplishments:
* Engaged BSI as registrar for ISO 13485:2003 and as notified body for eventual CE marking as part of initial effort to achieve certification. Increased focus by all relevant departments as part of staff acculturation required for successful quality system implementation.
* Assisted Product Development staff to create DMRs for all current products to meet regulatory requirements.
THERMOFISHER SCIENTIFIC, INC., Pittsburgh, Pennsylvania 08/2006 - 05/2007
Quality Assurance Director
Improved quality system to maintain compliance with ISO 9001: 2000 and FDA QSR requirements. Revised quality system administrative procedures; monitored performance of key process indicators; reviewed nonconforming materials; and managed Supplier Quality Engineer. Directly interacted with Field Service and Instrument Technical Support Manager to monitor customer complaints and product returns; and interfaced with Consumable Technical Support personnel to identify trends requiring CAPA.
Accomplishments:
* Organized and led teams consisting of myself, Supplier Quality Engineer, Materials Management, and Field Service to work directly with suppliers via regularly scheduled status meetings. Improved supplier relationships, resulting in quicker and more effective problem resolution.
* Successfully passed two ISO surveillance audits: one for entire site and one for mortuary fabrication business once the two business separated. Met organizational objectives to pass surveillance audits, resulting in mortuary fabrication business gaining separate certification while entire site was undergoing change and closure of certain departments.
INSTRUMENTATION INDUSTRIES, INC., Pittsburgh, Pennsylvania 08/2005 - 09/2006
Regulatory Affairs/Quality Assurance Manager
Assigned to upgrade and maintain quality system from ISO 13485: 1996 to ISO 13485: 2003 while remaining in compliance with all FDA QSR and Canadian MDR regulations. Managing three Quality Control Technicians and one Document Control Specialist, revised several quality system administrative procedures including Quality System Manual. Attended weekly production status meetings; developed, monitored and reported on quality metrics to management; and participated as QA representative in ISO certification audit and FDA inspection. Performed internal audits and led effort to implement any required CAPA. Managed customer complaint program, addressing and resolving problems; and worked directly with suppliers to resolve non-conforming material issues.
Accomplishments:
* Successfully achieved IO 13485: 2003 certification, meeting deadline imposed by Health Canada.
* Created and implemented new employee quality system overview training documentation and program to meet organizational needs and educate new employees.
UNIVERSITY OF PITTSBURGH MEDICAL CENTER IMMUNOLOGICAL MONITORING LABORATORY, Pittsburgh, Pennsylvania 08/2004 - 09/2005
Quality Assurance Director
Originally team member involved in re-integration activities, continued to maintain ImmunoSite quality system separately from IML quality system. Began engaging in IML quality system by reviewing procedures, performing internal audits and addressing necessary CAPAs. Maintained ImmunoSite client relationships and served as point of contact for ImmunoSite client study coordinators. Prepared specimen kits for ImmunoSite clients.
Accomplishments:
* Achieved College of American Pathologist accreditation for Immunosite operations to satisfy commercial client expectations.
IMMUNOSITE, INC., Pittsburgh, Pennsylvania 10/2002 - 08/2004
Quality Assurance Director
Collaborated with staff to create administrative and laboratory procedures. Established laboratory personnel training and competency assessment program, and internal laboratory proficiency program. Reviewed and monitored client issues, initiating CAPA as appropriate to resolve issues. Performed internal audits according to CAP requirements, and served as QA representative in external audits.
SUSAN C. MANTIA Page 3 *********@********.***
Accomplishments:
* Achieved CLIA certification and state licensure, enabling laboratory testing to commence.
* Working directly with laboratory technician, developed hands on experience with flow cytometer, resulting in more accurate and complete procedure.
CELLOMICS, INC., Pittsburgh, Pennsylvania 02/1999 - 10/2002
Quality Control Director (01/2002 - 10/2002)
Managed all quality control activities for both fluorescent microscopy based instrumentation and reagent manufacturing, including supervision of QC staff. Directing activities of two reagent QC staff, provided oversight to raw material and component testing, in process testing, and final functional testing of reagent kits to ensure testing met or exceeded established specifications. Co-managed instrument production with Manufacturing Engineer and Materials Management staff, assisting Manufacturing Engineer in drafting detailed instrument assembly, and in process and final functional testing instructions.
Accomplishments:
* Collaborated with Manufacturing Engineer to establish incoming instrument component review and testing procedures. customer expectations. Trained Reagent QC staff to perform some of the inspection tasks, leading to decreased numbers of issues normally identified during instrument assembly.
* Led efforts of R & D application specialists to develop final functional testing of instrument, resulting in increased instrument function reproducibility.
Quality Assurance Manager (01/2000 - 01/2002)
Managing two staff members, directed overall effort to initiate development of ISO 9001:2000 compliant quality system. Created several quality system administrative procedures, and participated in developing, documenting and implementing processes for product design and development. Acted as QA representative on design teams and attended design review meetings.
Accomplishments:
* Led team effort to create and implement documented design control process and procedure, providing structure to, and improving efficiency of design and development efforts.
* Spearheaded development and implementation of documented engineering change control process providing structure and guidance for changes on product and impact on other departments.
Manufacturing Manager (02/1999 - 01/2000)
Coordinated development of instrument and reagent manufacturing program. Drafted first round of reagent manufacturing procedures, and managed daily activities of instrument and reagent production staff.
Accomplishments:
* In collaboration with production staff, successfully produced reagent batches and first two instruments to meet goal and provide impetus for further process development.
Amersham Pharmacia Biotech, Inc., Pittsburgh, Pennsylvania 06/1996 - 02/1999
Site Manager
Managing two chemists, two molecular biologists, one buyer/planner and one administrative assistant, provided support to three R&D staff. Reported to Manufacturing Director of production site in Cleveland and participated in weekly production status meetings. Served as Team Lead for development and implementation of ISO 9002:1994 Quality System, directing all production staff in creating specific procedures, and developing all quality system level administrative procedures. Provided technical support to internal and external customers. Traveled to UK, Chicago and New Jersey to provide hands-on training and technical support, and conducted training activities for Japanese staff when in U.S.
Accomplishments:
* Developed site system and achieved ISO 9002: 1994 certification to meet company directive and customer expectations.
* Successfully transferred manufacturing and testing processes to UK production site and ensured employees were adequately trained in manufacturing, testing and trouble-shooting issues, enabling department to take over entire process.
EDUCATION / COMPUTER SKILLS / PROFESSIONAL AFFILIATION
M.S., Biochemistry - University of Pittsburgh, School of Medicine - Pittsburgh, Pennsylvania
B.S., Biochemistry & Recombinant Genetics - Western Kentucky University - Bowling Green, Kentucky
Currently pursuing Six Sigma Green Belt Certification
Microsoft Word, Excel, PowerPoint, Visio
American Society for Quality
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