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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E Dow Location: Princeton Junction, NJ 08550 ... leigh Healthcare is a manufacturer and distributor of medical devices. The product lines include DVT Prophylaxis Equipment, Patient Transport and Positioning equipment and Handheld Dopplers. I am responsible for all functions within the Quality and Regulatory areas that are regulated under 21 CFR - Part820 (Quality System), Part 803 (Medical Device Reporting), Part 806(Medical Device Corrections and Removals) and Part 821(Medical Device Tracking). I also serve as the Official Correspondent to the FDA. The manufacturing sites were certified to ISO 13485. There was a harmonized system and approach to quality with all Huntleigh Healthcare globally throughout the world.FDA ActivitiesHuntle ...
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R Robards Location: West New York, NJ 07093 ... lead and direct others at each level in the organization. More than 20 years experience in all key areas of logistics operations in a global environment. Adept at training and leading teams through strong leadership development, quality management, and through tools such as Lean, Kaizen, and Six Sigma. An influential leader with a clear vision and strong leadership skills. Possesses the skills to convey and execute key company objectives and strategic goals and plans successfully. A leader who understands the value of human resources, the voice of the customer, company values and focuses on the development of others. PROFESSIONAL EXPERIENCE WALLENIUS WILHELMSEN LOGISTICS, Woodcliff Lake ...
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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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W Richards Location: Mays Landing, NJ 08330 ... Broad functional background with expertise in a variety of administrative and technical areas, such as quality assurance/contro l, compliance, manufacturing process development, project management, method development and problem solving in Manufacturing and Laboratory operations (cGMP/DEA).Stren gths:A. Quality Assurance/Contro l1. Extensive knowledge of cGMP/USP/EP. In past positions: Performed as company liaison with FDA and DEA & Heavily involved during FDA Audits as company representative.2 . Developed Quality Assurance Protocols for Manufacturing and Laboratory operations and trained staff in their implementation for cGMP at manufacturing centers.3. Wrote, maintained & release ...
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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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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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B Denobriga Location: East Brunswick, NJ 08816 ... nting the requirements of cGMP's, GCP, GLP, CFR Part II, GAMP4 and SDLC. Skilled in reviewing, approving and implementing policies, procedures and work instructions for Operation and In-process QA activities during the manufacture of Solid Dosage products. Knowledgeable of manufacturing equipment and processes (Blenders, Dryers, Fitz Mill, Blenders, Tablet Press, Capsule Filler, Hardness Tester, Friability Tester, Packaging Equipment, Cleaning, Sanitizing). Monitored manufacturing operations, reviewed batch records, customer complaints, return/recall products, specifications and drug product labeling. Trained manufacturing team members and In-process QA associates on adhering to compliance ...
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K Bhatt Location: North Haledon, NJ 07508 ... ing and strong suits in editing SOPs, Master Manufacturing Formulas and Packaging Formulas, Quality Standards, and Protocols. Also known for extensive experience in electronic system - Quality Document Control System, QDCS (e-DocCompliance ) and QSi (Quality Systems International), as well as creative problem-solving, initiative, technical skills and knowledge of FDA, ANDA, laboratory and documentation. Recognized for “Above and Beyond” award. Professional Experience vyteris, inc., Fair Lawn, NJ July 2006 - Present Sr. QA Document Control Specialist / Complaint Coordinator, Quality Assurance Department Serve as System Administrator (System Owner) for electronic system QSi (Q ...
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S Magda Location: Howell, NJ 07731 ... xtensive experience in driving compliance and operations for manufacturers of pharmaceuticals, bulk pharmaceuticals, medical devices, chemicals, tissue products, and cosmetics. Areas of expertise include ability to: Analyze and upgrade existing policies and procedures into a user friendly compliant Quality System or implement a user friendly compliant Quality System. Conduct internal or external quality audits. Direct Quality Assurance/Compli ance functions. Conduct and/or support activities necessary for compliance of facilities, operations and products with applicable regulations, including cGMPs, QSR, cGTPs and ICH. Lead/coordinate new supplier, customer or product developmen ...
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