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Title : MKA- Quality Specialist - III (Senior) -389
State : Pennsylvania   Date : Sep 25, 2018
Experience Level :  
Position Type : Quality Specialist - III (Senior)      
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: West Point, PA

Job Title: Quality Specialist - III (Senior)

Duration:  12+ months (extendable) contract on W2


Specialist, Global Auditing Business Processes & Systems - The Specialist, Business Processes and Systems is responsible for maintaining assigned GMP auditing business processes and systems, including reporting reliable auditing metrics. The Specialist will support and lead continuous improvement projects as determined by the Director to help advance the auditing organization toward improved efficiency, data integrity, etc. This includes all supporting business processes and IT systems for auditing (End to End). The position will enable the Auditing organization to meet its business objectives and goals. The position will be responsible for developing, monitoring, trending, and reporting designated audit related data to understand and communicate the health of the Auditing QMS and the larger organization. The Specialist must be capable of working independently with limited supervision in a virtual-management environment. The Specialist will report to the Global Businesses and Systems Lead and will collaborate with Global and Site Auditors and other relevant  customers to meet customer demands and advance auditing business processes. // Job Description. Business System Administrator support for Auditing System: Coordinate training and assign individual user access privileges in the systems as needed and maintain approved user access forms. Responsible for maintaining system use and administrator procedures and custodial tasks for data, including answering questions regarding data. Perform administrative tasks related to auditing documentation. Assist in maintaining the audit schedule. Maintain global system for tracking auditors skills, job descriptions, resumes, and certifications. Responsible for updating audit team site and ensuring content is current and relevant. Responsible for generating and reporting metrics/KPIs. Assist Auditors and sites with Regulatory Agency requests related to audits. Assist with maintaining knowledge management tool 


Minimum 5-10 years applied professional work experience working in one or more of the following areas: auditing, IT systems, manufacturing operations, quality organization, supply chain, technical operations, process research or development environment. Prior experience in a Quality organization and prior experience working as part of a global program. MPS experience preferred. Prior experience as part of cross functional teams, comfortable with speaking up and having diversity of thought. Solid understanding of Quality activities and functions. Working knowledge of auditing principles and the understanding of the roles and responsibility of the related function is a plus. Risk based decision making knowledge and skills. Collaborative and communication skills within teams and across the company. Communication skills. Organizational and time management skills and demonstrated ability to independently manage multiple priorities, deal with ambiguity, changing priorities, aggressive deadlines, and ensure timely completion of deliverables. Strong work ethic. Demonstrated strong teamwork skills. Experience working with Trackwise application. Archer application use a bonus. 


BS degree required, concentrations in Science or Engineering (chemical or mechanical engineering, pharmacy/pharmaceutics, chemistry, biology).


Many Thanks,   

Sree Kanth
Associate Recruitment Manager
NewAge Clinical,
A Division of NewAgeSys, Inc.
231 Clarksville Road, Suite 200,
Princeton Junction, NJ 08550
Tel#: 609-945-1736, Fax: 609-228-4079

Inc 5000 Company for 8th Time 

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