E Rugel Location: Paterson, NJ 07522 ... s quickly, team player, punctual, and loyal. Languages: Fluent Spanish/English and excellent translator Professional Experience: May 2008 – presentParagon MedicalFairfield , NJ Document Controller Specialist Ensure all Quality Management System documents are properly controlled, maintained and protected. Continuous analysis and improvement of document control protocols, systems, and processes, ensuring both internal and external regulatory requirements are met, including maintenance and improvement of facility wide training and training tracking system. Maintain an in-depth working knowledge of ISO and FDA requirements. Responsible for reconciliation and training of document ...
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B Auch Location: Clayton, NJ 08312 ... ngton Township High School; High School Diploma Graduated 1996 Management Institute at Rowan University; Total Quality Management Course ISO 9001:2000 Training GMP (Good Manufacturing Practices) Training Time Management Manager/Supervis or Employee Training JCAHO Training American Society for Quality; Basics of Calibration Course Mechanical Technician Certification Internal Auditor Course (RABQSA Certified) US Food and Drug Administration; Is It A Device and How Do I Bring It To Market (13485/ QSR) (Bryan H Benesch Director of Compliance FDA Administrator) Experience Aerotek/ AALL American Fasteners Cinnaminson, NJ 2007-Present Quality Manager/Complian ce Consultant (Contractor) Ass ...
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H Anderson Location: Robbinsville, NJ 08691 ... ertified Quality Auditor (CQA) solving your quality issues and improving your quality system:Document/ Data auditor for Quality Management System, cGMP, GLP, ICH, EP, USP, NF, DEA, SOPs, protocols, FDA compliance, and related items in a pharmaceutical environment.Revi ewed, edited and wrote SOPs ensuring accuracy, clarity and compliance with all applicable guidelines.Write , develop, and perform Validation Protocols (IQ/OQ/PQ) for new systems/equipmen t.Effective team leader and change agent who developed and motivated highly efficient, self-directed teams.Performed, developed and/or validated a wide variety of analytical methods.Improved overall quality, while reducing costs more than $1 ...
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A Pryor Location: Neptune, NJ 07753 ... nd organize all Quality Assurance and R & D documents Proofread and label copy of protocols for products Provide technical support for products for DNA/protein research Revise and develop company documents to conform to current company protocols, as well as GMP, FDA, and ISO-9000 protocols Participate in vendor audits, customer complaints/inqui res and resolution Routine testing of incoming raw materials, product samples and components QC all finished goods (regulated and non-regulated), prepare products for release Calibration of all measurement equipment, housekeeping audits Daily monitoring of all GMP compliance activities, assure employees comply with company polici ...
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I Jorge Location: Morristown, NJ 07960 ... to provide strength to current processes and influence new global strategic initiatives and programs. Manager and auditor with documented results assuring FDA compliance by combining procedural knowledge with the expertise of cGXPs. Certified technical writer noted for using technical, communication and leadership skills to successfully rewrite and implement corporate SOP programs. Skilled negotiator of corporate and departmental external vendor agreements. Author of chemistry, manufacturing and control section (CMC) of NDA / IND, protocols and critical documents. Demonstrated ability to combine scientific, mathematical and technical skills in developing process improvements. PROFESS ...
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N Siddiqi Location: Lakehiawatha, NJ 07034 ... growth based on performance. Experience Testpak Inc. Sept. 2004 – Till date. 125 Algonquin Parkway Whippany N.J. 07981 Quality Assurance Dept.. Quality Assurance Inspector/Custom er Service Using Forth Shift Software. Verify that all required job documentation are properly filled. Verify that materials received from clients and vendors are properly identified and accounted for upon receipt and are suitable for their intended purpose prior to use. Conduct all in-process testing, sampling and needed to assure that each job conforms to all established contractual, regulatory and quality standards. Compare drug product with library sample and make sure it is correct. Approve the d ...
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R Ward Location: Somerset , NJ 08873 ... task Enthusiastic, reliable, hard-working, and flexible Knowledge of cGMP, cGLP, SOP’s, Clean room, MS Office Suite WORK EXPERIENCE Operations Assistant 3/07- 7/07 Enzon Pharmaceuticals South Plainfield, NJ Performed visual inspections and labeling and packaging for final product Sterilizes and maintains all clean room processing area and equipment Skilled in using and handling manufacture caustic chemicals Reconcile all paperwork needed during processing Order necessary supplies to carry out the quality technical functions Experience with proper sterile technique and working in a class 10 environment Processing Technician 6/05-3/07 Life Cell, Branchburg, NJ Respo ...
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A Perafan Location: Bound Brok, NJ 08805 ... To obtain a position that offers opportunities for growth and personal development. Summary of qualifications Significant, progressive experience in Pharmaceutical Manufacturing operations culminating in the review and reconciliation of batch records and release of finished goods. Extensive knowledge of GMP, Filling, labeling and packaging operations. Strong documentation control, production planning, Inventory control. Knowledge of MRP systems such as JDEdwards. Able to operate and troubleshoot mechanical equipment. Good written and verbal communication skills. Familiar with major computer software packages and document control systems such as QUMAS, Smartsolve, ConDoc Micr ...
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B Younger Location: Jersey City, NJ 07305 ... nistration.. Specific industry experience includes: Co-Gen Power, Alternative Fuels, Mining, Rapid Rebuild, Quality Control Labs, Pharmaceutical Life Sciences, and Infrastructure and Industrial. As Technical Document Control Manager performed QC review, editing, producing and expediting of construction, architectural, and design documents while supervising a staff of 4 individuals. Have considerable knowledge of engineering/cons truction terminology, building codes and permitting requirements, applied during collaboration and reviewing, logging, tracking and field issuing of documents on several concurrent projects in excess of $100mm. Possess the ability to interact with ...
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P Mendel Location: Sea Isle City, NJ 08243 ... _______ Summary: Education, Work History * Quality Assurance Documentation Supervisor * Manufacturing Supervisor * Company Trainer 7 years * Internal & External Auditing * Customer & Supplier Audits * Medical Device Manufacturing * Inventory * Scheduling * Computers - Mapics & SAP - R/3 System & 4.6 * Microsoft Office 2000 & XP, Windows NT Explorer, Lotus Notes 4.5, Pilgrim * Team Player * Customer Service * Office Support * AALAS Certified - Animal Laboratory Technician * Certificate in Total Quality - Camden County College ________________ ________________ ________________ ________________ ________________ __ Qualified by: 25 Years Experience Medical Device/Pharmac ...
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