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Senior Specialist, Quality Management Systems West Point United States,  


Posted on : 25 May 2017

Project Description

Senior Specialist, Quality Management Systems-QUA005919DescriptionMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.This Senior Specalist position within the Analytical Standards group is looking for an ambitous, process improvement enthusiast with Product Release Testing and Change Control Exeperience help us define the future of analytical change control on the Harmonization team in the Analytical Standards (AS) group.In this role, your focus will include:- Improve the compliance for release/stability tests and methods for all Merck products globally by executing a strategy for harmonizing release tests and specifications from Legacy, Outsourced, and acquired products into the AS system- Support licensure and launch of all new products by creating AS to support manufactureTo be sucessful in this role, which works with a diverse slate of customers across organizations globally, both strong technical skills and interpersonal skills are critical. Therefore, you should posess the following traits:- A strong analytical background with small molecule, vaccines, raw materials, or biologics experience- The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries- Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with Merck s long term strategy- Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level.QualificationsEducation Minimum Requirement:- Bachelor s Degree in a science or engineering discipline or related fieldRequired Experience and Skills:- Thorough understanding of regulatory requirements for drug products and/or medical devices.- Minimum 7 years experience in analytical laboratory for release testing or drug development.- Use of the Trackwise Program for change control.- Hands on experience running a variety of analytical methods, which would include two or more of the following: HPLC, densitometry, dissolutions, particle sizing, gel electrophoresis, spectrophotometric assays, immunoassays, cell based assays.Preferred Experience and Skills:- Ability to accurately interpret and apply expectations for global compendia- Experience with CMC and product filings and the ability to accurately interpret and apply regulatory expectations to the AS.- Previous experience creating AS as part of a product development team or commercialization team.Our employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.Search Firm Representatives Please Read Carefully:Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.Visa sponsorship is not available for this position.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Quality Sys/CustSatisfactionJob Title:Sr. Spclst, Quality Systems & CompliancePrimary Location: NA-US-PA-West PointOther Locations: NA-US-NJ-Whitehouse Station WestEmployee Status: RegularTravel: Yes, 20 % of the TimeNumber of Openings: 1Shift (if applicable): 1stCompany Trade Name:Merck Nearest Major Market: Philadelphia Job Segment: Medical, Manager, Engineer, Law, Product Development, Healthcare, Management, Engineering, Legal, Research

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West Point PA US

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