Manager Quality Assurance

Ronald A. Hirte II

*** ******* *** • New London, CT • 06320

603-***-****(c) • ********@*****.***

Summary of Qualifications

Ambitious and well organized individual with extensive knowledge in pharmaceutical research, manufacturing of pharmaceuticals, rubber and automotive finishes • Demonstrates expertise in cGMP and GLP regulations and practices • Ability to meet and exceed deadlines, thrives in high pressure environments, and works proficiently both independently and as a team • Professional team leader with management and training experience; technical problem-solving skills, and the proven ability to optimize resources to maximize production and ensure quality • Proven track record of managing multiple tasks successfully • Dedicated, dependable, enthusiastic, flexible and motivated self starter with excellent analytical, organizational, mathematical, writing, communication, and interpersonal skills.

Education

Minisink Valley High School • Slatehill, New York • 1992-1996

Orange County Community College • Middletown, New York • 1996-1998

Dominican College • Orangeburg, New York • 1999-2001

Technical Skills and Equipment Knowledge

SpectraMax Plate-Reader • A280 Nanodrop • LAL Endotoxin Assay's • PCR • Mycoplasma Assay's • Kinetic Scientific Licometer and Locometer program • AS/400 • RF Scanners • SAP Computer Software • Inspection Equipment: Eisai inspection system EIS 296 • Packing equipment: Denester, Labelers, Accumulator, Thermoformer, Cartoners, and Bundlers • Component preparation equipment: Tunnel Washers, Autoclaves & Cage Washers

Computer Skills

Spectramax Plate Reader • Lab Guru • Knowledge in SAP transactions • AS/400 • LACES LIMS • Many other types of computer software packages such as: Microsoft Word, Excel, Word Perfect, Outlook, GroupWise, Power Point, and Internet Explorer. Knowledge in both PC & Mac computer based software

Employment History

Laboratory Manager/Quality Assurance • Immunext Inc. • January 2013-Present

Organizes Employee Records • Provides laboratory information, products, and services by establishing specimen preparation procedures; developing and implementing analytical procedures; evaluating laboratory information; consulting with Immunologists; reporting results according to protocols mandated by the company’s QA/QC department. • Maintains laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair. • Achieves no pause in laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies. Negotiates pricing with vendors. Developed QA/QC program for all reagents and incoming antibodies • Maintains quality results by participating in the quality assurance program; consulting with scientists; implementing quality control and quality assurance programs; making adjustments in policy and procedures; generating reports; maintaining records. • Screens laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing;; training employees; maintaining security and confidentiality. • Implements new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress. • Leads laboratory staff by orienting and training employees. • Completes operational requirements by scheduling, assigning employees and following up on work results.

Technician • Dr. Radu Stan of Dartmouth College • May 2012-2014 • Lebanon, New HampshireCollects and provides DNA/Genotyping samples • Responsible for weekly inventory of colony production • Organizes and maintains colony records • Assists in various activities when needed and requested. • Technical skills acquired: (Mice) Tag and Tailing, IV Injection, IP Injection, Heart Stick, Sub- Q injections, Gavaging.

Technician • CCMR of Dartmouth College • July 2011-2013 • Lebanon, New Hampshire

Provides assistance for Veterinarian staff in daily procedures • Mixes and calculates chemical compounds for cleaning sterilizing agents • Prepares and autoclaves all research equipment • Reports to lead scientist and research technicians for all changes of animals during daily monitoring of studies for change in physical and mental well being of all animals including monkeys; mice; rats; hamsters; and swine • Regulations in Animal Welfare Act, in-house animal welfare laws and protocols, state and federal laws, USDA, etc.

Supplier/Serviceman • Goodyear Tire & Rubber Co. • December 2010-May 2011 • Fayetteville, North Carolina

Supply tire machines with raw materials for tire assembly • Maintain inventory for a “no pause” in production at all times Notify Are Manager/Component prep of any shortages • Maintain AS/400 computer software for an up to date inventory at all times.

Warehouse Manager • Coventry Coatings Corporation • July 2009-September 2010 • Newburgh, New York

Supervise workers of orders, cross-over’s, daily procedures, training, verifications, etc. • Accountable for all bills of lading, weight limits, hazardous and flammable material, MSDS • Responsible for Knowing International and U.S. Customs requirements for shipping • Maintain production and shipping schedule • Responsible for notifying production of shortages • Responsible for dividing gallon amount on production tickets to required volumes for orders, labeling for private companies and required filling instructions • Weekly inventory’s of company stock and private label stock • Overall quality assurance of product and it’s packaging • Responsible for weight amounts of orders • Daily back orders • Maintaining clean and orderly area at all times.

Supervisor • Coventry Coatings Corporation • June 2008-July 2009 • Newburgh, New York

Supervise workers on filling instructions ex: labeling requirements for private labels, proper filters for types of paints and lab requirements • Daily inventory of supply’s required for filling • Follow daily procedures to meet demands of out going orders • Maintain floor flow and productivity.

Manufacturing Production Supplier • Wyeth Pharmaceuticals • August 2006-June 2008 • Pearl River, New York

Help supervise daily supplier operations and maintain a high level of floor presence • Accountable for daily supervision and training of supplier trainees in production of clinical and commercial products including accurate and timely completion of production related cGMP documentation • Provided training and leadership to ensure that employees are performing assigned work properly • Responsible for ensuring that the production filling area is in compliance with SOP’s, GMP’s, safety and company polices • Responsible for all SAP transactions of incoming/outgoing components such as product, parts, syringes vials, stoppers and clinical products • Responsible for LACES LIMS of all product and follow up training • Providing operational support for related SOP’s MIR’s Batch Records, etc. • Following company and regulatory protocols (i.e. SOP’s, GMP’s, PBR’s, PMO’s, etc) • Recognizing and reporting irregularities in machine functions and floor conditions • Responsible for knowing, practicing, and following all gowning requirements in class A, B, C areas of Aseptic Areas • Provided documents, components, coordination, and supports during production.

Technician • Wyeth Pharmaceuticals • June 1999-August 2006 • Pearl River, New York

Responsible for daily husbandry of lab animals (nude mice) and the micro and macro environments of the In-Vivo Cancer areas • Regulations in Animal Welfare Act, in-house animal welfare laws and protocols, state and federal laws, USDA, etc. • Providing assistance for Veterinarian’s in surgical and daily procedures • Mixing and calculating chemical compounds for cleaning sterilizing agents • Preparing and autoclaving of all cancer research equipment • Reporting to lead scientist for all changes of animals during studies • Daily Monitoring of studies for change in physical and mental well being of all animals including monkeys; ferrets; swine and dogs • Provided assistance in Telemetry studies, Influenza studies etc.

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