MARIA C. DOMENICI aczaoh@r.postjobfree.com 413-***-****

PO 435 Shelburne Falls, MA 01370

MEDICAL TECHNOLOGIST / WRITER / EDITOR

Highly knowledgeable, detail-oriented, and results-driven professional with extensive clinical laboratory experience combined with solid technical writing background. Sound understanding of multiple industries including pharmacology, microbiology, and biotechnology. Demonstrate high levels of initiative and problem-solving skills in complex scientific environments. Manage projects from inception to completion that deliver innovative solutions to desired organizational requirements. Expertise in drafting technical manuals, GMPs, SOPs, procedures, policies, protocols, regulatory documentation, audit reports, and manuscripts for peer journal review/submission. Strengths include:

Research & Development FDA, CFR 21 & ICH Regulations Quality Assurance Data Analysis Issue Resolution

Process Improvement Site & Trial Monitoring Materials Management GCP, GMP & SOP Compliance Patient Safety

CAREER HIGHLIGHTS

Designed, optimized, and implemented Access aphaeresis computational database for National American Red Cross, enabling accurate monitoring of participating aphaeresis donor statuses and ensuring delivery of safe, pure, and potent products.

Authored GMP compliance documents as required by CFR 21 for Repligen Corporation, covering process development, quality assurance, quality control, and regulatory affairs; established/standardized formats and documentation processes for microbiology and environmental monitoring procedures.

Wrote and edited various medical training, 510K, and technical materials over course of career for products including beta blocker, DNA synthesizer, immunofluorescent analytical device, non-invasive device, and albumin-coated graph.

Researched and drafted compendium on the advancements/developments of growth factor technologies for Yale University.

COMPUTER SKILLS

Software: MS Office Suite (Excel, PowerPoint, Access), Adobe Creative Suite (PageMaker, FrameMaker, Photoshop, InDesign), SAS, BASIC, RoboHelp, Ventura, QuarkXPress, Lotus 123, Quattro Pro, FileMaker Pro, WordPerfect for Windows, MacWrite, MacDraw, MacPaint, HyperCard, Harvard Graphics, MultiMate, WordStar, MEDITECH, IDX, CPSI.

Operating Systems, Mainframes, Hardware: DEC, VAX, IBM, Data General & Prime Mainframes, PC & Macintosh, Novell Local Area Network, DOS, Windows 97

PROFESSIONAL EXPERIENCE

CACTUS COMMUNICATIONS

Freelance Science Editor

Edit foreign manuscripts such that the final text is in standard scientific English and is free of unclear or unidiomatic sentences. Adhere to job-specific instructions and format manuscripts according to the target journal when required. Ensure that all subject-specific conventions are followed

CRIMSON INTERACTIVE

Freelance Content Science Editor

Edit and double check manuscripts to ensure an error-free output in order to meet international standards of publication

NOBLE HOSPITAL, Westfield, MA 2005 to Present

Evening Medical Technologist

Provide evening and on call night shift coverage in blood bank, hematology, chemistry, and microbiology departments. Operated Cobas Integra, Hitachi Elecsys, Bayer blood gas analyzer, Cell-Dyne hematology analyzer, and MLA coagulation instruments. Utilized MEDITECH LIS.

HOLYOKE MEDICAL CENTER, Holyoke, MA 2010 to 2011

Bacteriologist

Completed routine culture and sensitivity testing to identify gram negative/positive bacteria and chlamydia and gonorrhea by DNA amplification.

ATHOL MEMORIAL HOSPITAL, Athol, MA 2009 to 2010

Night & Per Diem Medical Technologist

Served in clinical laboratory for acute-care hospital. Used/troubleshot Dimension XP Plus, Sysmex xt2001 hematology analyzer, Sysmex CA-5000 coagulation analyzer, Pochi-100i hematology analyzer, triage meter, and CPSI laboratory information system (LIS).

FAMILY HEALTH CENTER, Worcester, MA 2006 to 2007

Medical Technologist

Held generalist role for walk-in, urgent, and primary care center. Supported all laboratory departments including hematology, microbiology, serology, urinalysis, and chemistry.

UNIVERSITY HEALTH SERVICES, UNIVERSITY OF MASSACHUSETTS, Amherst, MA 2004 to 2005

Bacteriologist

Worked in hematology, chemistry, and microbiology departments for clinic serving entire University of Massachusetts population and other area colleges. Performed routine culture and sensitivity tests to identify gram negative and positive bacteria and utilized GenProbe to identify chlamydia and gonorrhea.

COHESIVE TECHNOLOGIES, Franklin, MA 2000 to 2003

Science Writer

Authored user manuals and accompanying compliance documentation, on-screen help files, and installation, performance, operation, and preventive maintenance protocols. Created materials for software validation and CFR 21 GMP electronic signature compliance. Developed marketing pieces for turbulent flow columns. Utilized InDesign and RoboHelp software to produce all documents.

NASHOBA VALLEY MEDICAL CENTER, Ayer, MA 1999 to 2000

Bacteriologist

Identified gram negative and positive bacteria, non-fermenters, fungus, anaerobes, acid-fast bacteria (TB), Cryptococcal antigens, and C. difficile via routine and ELISA testing. Additionally hired to oversee preparation and conversion to MEDITECH system and train technologists on use; independently managed department operations. Used BacT/Alert, Microscan, and Antrim LIS.

NATIONAL AMERICAN RED CROSS, Dedham, MA 1994 to1999

Quality Assurance Specialist

Performed/Completed regularly scheduled internal and external cGMP audits in manufacturing, testing, collection and distribution. Wrote audit and complaint investigation reports with corrective action analysis and recommendations. Pursued completion of subsequent corrective action results. Performed tracking/trending data to identify trends and evaluate data for root cause analysis. Participated in inspections for FDA, NRC, AABB, CLIA, New York State, and ARC. Participated in review and approval of SOPs before implementation, Errors and Accident reports prior to FDA submission and Validation Plans for equipment and processes. Attended Material Review Board to determine suitability of products for release. Created, revised, employed and trained other Quality personnel to operate the Access aphaeresis computational database that monitored participating aphaeresis donor(s) status and the assurance of the implementation and release of a safe, pure and potent product. Participated in 21 CFR electronic signature compliance and software validation completion for ARC computer system national consistency program. Wrote and trained other Red Cross Quality personnel to utilize the National SOP for FDA inspections.

INTERQUAL, Marlboro, MA 1993 to 1994

Medical Writer

Researched, wrote and edited utilization review documentation for many different clinical specialties, clinical protocols, and summaries for External Peer Group Review (EPR) reports.

REPLIGEN CORPORATION, Cambridge, MA 1990 to 1992

Quality Assurance Specialist

Wrote/Performed GMP compliance regulated documents according to CFR 211 for Process Development, Quality Assurance, Quality Control and Regulatory Affairs. Special projects included establishing formats and documents for Microbiology and Environmental Monitoring procedures. Writer for major growth factor and monoclonal product, maintenance and support for Quality Assurance Macintosh on the Novell Local Area Network.

SOUTHBOROUGH, MA 1998 to 1989

Independent Consultant

In depth knowledge of GMPs. Experience with batch record review and knowledge of batch release. Ability to work well in a project team environment. Good oral, written, and presentation skills. Write technical manuals, pharmaceutical marketing materials, FDA submission materials, protocols, SOPs, device specifications and descriptions, utilization review and clinical criteria protocols, grant applications, GCP, cGMP and non-clinical GLP audit reports. Knowledge of 21CFR electronic signature regulations and software validation. Prepare and Clinical Study Reports, Investigator's Brochures, Safety and Efficacy sections. Prepare manuscripts for peer journal review/submission. In-depth working knowledge of GCP, CFR 21 and ICH regulations. Therapeutic experience and knowledge in immunology, CNS, anti-infectives, and viral agents. Excellent organizational, written and oral communication skills and highly self-motivated. The list below outlines different clinical and FDA regulatory documentation I have worked on for different Biologics, Devices and Drug products:

Freelance Projects include:

Total Learning Concepts, Boston, MA

Researched and wrote sales training materials for a beta blocker.

Analytical Biosystems, Milford, MA

Wrote and edited technical GMP regulated manuals for DNA synthesizer.

Core, Boston, MA

Wrote and edited technical manuals for Managed Care software system.

Yale University, New Haven CT

Identified and utilized credible resource material to gather research for and wrote a compendium of advancements and developments of evolving technologies in the field of growth factors.

PB Diagnostics, Westwood, MA

Wrote and edited GMP regulated user and service manuals and 510K for immunofluorescent analytical device.

Cambridge Biosciences, Worcester, MA

Wrote a Canadian submission for non-invasive device.

Bard Diagnostics, Billerica, MA

Wrote various sections including toxicology, adverse event reporting and GMP regulated manufacturing for an albumin-coated graph.

Ceramics Processing System, Watertown, MA

Wrote GMP regulated Quality manual and SOPs for ceramic semiconductor manufacturing site.

Prime Computer, Natick, MA

Edited different versions of Prime's Office Automated system manuals.

Additional Experience:

Occasional Workforce & Per Diem Bacteriologist – Faulkner Hospital, Boston, MA

Clinical Auditor – Marathon Corporation, Hopkinton, MA

EDUCATION & PROFESSIONAL CREDENTIALS

BA in Psychology, Olivet College, Olivet, MI

Certified Medical Technologist (MT), American Society for Clinical Pathology (ASCP)

Pharmaceutical Certification in Regulatory Submission (in progress), American Medical Writers Association (AMWA)

MS Courses in Public Health (Biostatistics and Epidemiology), University of Massachusetts, School of Medicine, Worcester, MA

MS Courses in Reporting for Science and Medicine, Boston University, Boston, MA

PROFESSIONAL MEMBERSHIPS

American Society for Clinical Pathology (ASCP), American Medical Writers Association (AMWA)

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