Maintain all company cGDP documentation for cGMP documents. Track training records and update trackers. Write and edit SOPs, forms and WI. Currently ISO9001 certified company preparing for initial ISO 13485 Audit which we got with no major or minor findings.

IT Documentation Management. Coordinating SOP, Validations and Deviations for the IT MFG Group.

Client Service Specialist• Responsible for building and strengthening client/account relationships by responding to inquiries and resolving concerns with specimens and requisitions.• Effectively communicate with clients via email, telephone, or fax to assist with problem identification and/or resolution to achieve customer satisfaction.• Develop and maintain client database• Identify and develop process improvement opportunities.

• Prepare and manage cGMP best practice documentation of new and revised SOPs, work instructions and guidelines. • Administrator of MC users and roles.• Replace and obsolete hard copy documentation.• Manage records room including indexes for retrieval of all SOPs, ECN, Deviations, Standards & Regulations.• Load new Documents into MasterControl and manage the workflow through final approval.• Help desk for any issues Document Owners may have using MasterControl to process their documents.• Assist with product validations, batch review and archiving of records• Applies knowledge of FDA, ISO 9001,15189,13485, ICH, and Canadian regulations and guidelines to document reviews

Transitioned over 2000 documents from an ECM (Livelink) to MasterControl, LabCorp's document storage software with a 98% accuracy outcome. This transition was completed in a greatly shortened amount of time resulting in a large financial gain for LabCorp.

Prepared and Managed best practice documentation while standardizing 9 sites to create consistency within entire organization to meet established regulatory compliance which resulted in excellent results for Quality audits. Collaborated on the development of workflows. Livelink administrator and portal editor for the Quality group.

Wrote Processes detailing set up of machinery through final electro mechanical and finish work for the manufacture of electronic devices using visual aids and technical writingMaintained and distributed paperwork using MS Office, AutoCAD, CMS, Unicam, AE and Agile

Set up and managed all accounting systems (A/R, A/P, Purchasing, Payroll, etc.)Analyzed then contracted programs offered by insurance, banks and vendorsDeveloped and maintained spreadsheets to track hundreds of AAA service calls monthly.Developed system to process payroll for commissioned and non-commissioned personnel.

Responsible for all A/P functions.Audited consultant bills to determine reimbursement eligibility in accordance with state Underground Storage Tank (UST) guidelines. Attended State Board meetings monthly to keep apprised of changes and challenges of UST guidelines and issues. Prepared all accounting and legal documents for reimbursement packages.Researched and defined descrepancies from previous claims and submitted corrections.MS Access database management and analysis, troubleshoot descrepancies.

Supported the Director of Engineering, 9 functional managers and 150 engineersConverted office procedures and protocols resulting in improved timely reporting of key data Handled all administrative duties: filing, faxing, answering phones, correspondence, travel arrangements, expense reports, budgeting updates and scheduled appointments and conference rooms