N Shah Location: Westborough, MA 01581 ... rnational pharmaceutical industry. Strong commitment meeting regulatory requirements and quality standards including but not limited to cGXP, FDA, ISO, ICH etc. Proficient in multiple pharmaceutical computer applications. Ability to cultivate productive working relationship with co-workers and others. Reputation for initiative, autonomy and proficiency. A multi-tasker having excellent time-management, organization, prioritization and attention to details skills. Masters degree in Chemical Biology and Bioinformatics with 3 year of quality assurance and analytical quality control experience, 5 years of medical sales and administration experience. Leadership skills include training others. A ...
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G Sinkus Location: Hubbardston, MA 01452 ... ical expertise. MANAGEMENT: Excellent leadership, communication, organizational and technical skills 15 plus years professional management experience in the following areas: Operations (test – system and board) in an ISO 9002 environment utilizing quality control (SPC, CI, Six Sigma environment, Lean Manufacturing/Pr oduction etc.) methodologies. Engineering and Development (hardware and software) – computers, switches, routers, storage. Production controls (MANMAN, MRP II, JIT) Project Management, Lean Manufacturing/Pr oduction. Purchasing, Planning, Budgets in a variety area’s Significant cross-organizati onal experience and multi-functional team leade ...
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C Downs Location: Lowell, MA 01852 ... calculations, W2’s, Bank statements, Tax Returns, per Delta guidelines. Strong mathematical skills. Ordered Flood Certs, Building Violations, verifications of self-employment per the guidelines. Preliminary QC of all documentation. Working on complicated files by changing the structure of the loan to meet the guidelines required by Delta. Work with Account Executives and Brokers to complete conditions required to finalize the loan. Coordinated with the closing department to insure timely, accurate closing docs were sent. Training of Jr. Account Manager. Delegating to other staff members as needed to complete loan files. Strong relationships with all office members, strong team player. Ass ...
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M Comeau Location: Haverhill, MA 01832 ... sPortsmo uth, NHQA Compliance Specialist IIIResponsible for reviewing, editing, disposition, approving and closing deviation/invest igation reports.Scheduli ng and performing product change-over procedures for manufacturing on an as needed basis.Lead audit teams for internal cGMP audits, including writing of audits/observati ons, reports and tracking resolutions of corrective actions. (CAPA).Participa te as needed with the on-going cGMP training of employees through the current training program. This includes presenting cGMP training materials to new or current employees upon request.Coordina te and review various applicable Quality Systems documentation applicable to the production area(s) ...
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D Renaud Location: Lakeville, MA 02347 ... Manufacturer of urethane and rubber components for industry, marine and military February 2006 to July 2008 Director of Quality Assurance Responsible for all phases of the Quality operation, review and interpret government contracts, oversee government source inspections. Appointed Facility Security Officer. Wrote Quality Policy Manual, all QMS documentation to successfully implement and achieve ISO 9001:2000 certification. Lead Internal Auditor. Leviton Manufacturing Company Inc. November 1994 to January 2006 January 2001 to January 2006 Quality Assurance Manager/Facility Maintenance Manager Promoted to assume additional responsibility of ma ...
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S Berian Location: E Longmeadow, MA 01028 ... OFILE: § Savvy technical generalist, servant leader, LEAN-Six Sigma Black Belt, change agent & problem solver with deep manufacturing experience. § ASQ Certified Quality Auditor, Engineer & Manager § Working knowledge of ISO-9000, 10012, 13485, 14000, 16949, 17025, & AS-9101 standards. Successfully installed & maintained ISO-9000 quality management systems at four firms. EXPERIENCE: Supervisor: Process & Product Quality UTC Power, S Windsor, CT 2006 to 2009 UTC Power, a unit of United Technologies Corporation, builds environmentally advanced power sources, including military & commercial vehicular & stationary fuel-cell power plants; ...
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R Remy Location: Canton, MA 02021 ... , continuous improvement, auditing, inspection, and a proficient user of all quality tools (FMEA, Gage R&R, GD&T, SPC, 8D, 5S, Cpk analysis, CAPA, etc.). Natural team builder/player, hands on, detail oriented, analytical, and experienced in working with strict regulatory requirements such as ISO, GMP, FDA, Defense, and ASME.EXPERIENCEQ uality Manager Symmons Industries, Braintree MA 2008 - 2009Directed, scheduled, and implemented all inspection activities (vendor first article, machine first piece, and incoming) to ensure timely, complete, and accurate results and provided immediate supplier (internal/extern al) notification of inspection results with corrective action direction ...
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T Curley Location: Linwood, MA 01525 ... cal Process Control, documentation control, procedure development and maintaining Process Control and Quality Management Systems.Certifie d as: Lean Six Sigma Green Belt (Cert# 080709-LG1), Lean Manufacturing Expert (Cert# 092509-E4), ISO 9001:2008 Auditor (Cert# 090109-5) and Lean Supply Chain Professional (Cert# QPS090209-2).Ski lls and QualificationsEx perience in Quality Assurance and maintaining Quality Management Systems/ISO 9001 certification. Strong computer skills with Microsoft Office Professional 2003 and MS Visio programs. (Recently completed MS Office Level 2 courses through Employment Training and Resources, 2009)Enjoy learning and developing new skills. Ability to work with ...
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J Cipolla Location: Norton, MA 02766 ... owing is a brief summary of my skills and core competencies: ¨Management Team Experience- Responsible for providing leadership and direction to the Management Team on all quality related matters. I lead the 13485,AS9100/ISO 9001-2000 Quality Management System certification efforts, which included the upgrade/transiti on from the ISO 9001:1994 to the ISO 9001-2000 standard. External Regulatory (FAA & FDA ) Agency Interface - Responsible for maintaining proactive communications with the Federal Aviation Administration (FAA) for all new product introductions and the coordination of FAA 1st article conformity inspections. Employee Training & Development - Developed company Qua ...
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C Charles E Wehner Location: Milton, MA 02186 ... Auditor 7 Francis Street ~ Milton, Massachusetts 02186 Home: 617-696-0127 Email: charliewehner@ya hoo.com OBJECTIVE For over thirty five years, I have been employed in Manufacturing Management in various capacities and have enjoyed the daily challenges it presents. During the last three years I have been involved with contract work in many other capacities including Qu ...
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