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Specialist, Quality Assurance Job Elkton United States,  

Posted on : 03 May 2017

Project Description

Specialist, Quality Assurance-QUA005769DescriptionMerck & 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.Position carries out a variety of activities to support operations becoming familiar with site processes, procedures, and policies assuring alignment with cGMPs (current Good Manufacturing Processes) and Health Authority regulations. Conducts batch record reviews, audits, investigations, and helps with internal audits / external inspections. Supports sampling requirements for several areas. Performs quarantine functions and accountability reviews. Supports special projects as assigned. Follow cGMP and routinely makes decisions using cGMP/process knowledge. Works with customers to resolve problems and to satisfy quality and production needs. Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance. Follows site safety requirements. Authors, reviews, and or approves data and documents such as methods, procedures, and protocols. Completes assigned projects. Performs all work in a timely manner and is an active member of 1 or more teams. Tracks/reports metrics.The open position is currently assigned to an aseptic, antibiotic filling line though assignment of work can apply across the antibiotic process (bulk existing and capital project) at the site.QualificationsEducation Minimum Requirement:- Bachelor s of Science (engineering, biology, chemistry, etc.)Required Experience and Skills:- 2 years  experience in Pharmaceutical, Food, or GMP related industry or Quality Assurance/ControlPreferred Experience and Skills:- Demonstrated verbal/written communication and decision making skills- Experience with GMP/compliance requirements for food or pharmaceutical industry; technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding; sterile/aseptic processing experienceOur 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 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: Qual Assurance & Ops GenericJob Title:Spclst, Quality AssurancePrimary Location: NA-US-VA-ElktonEmployee Status: RegularNumber of Openings: 1Shift (if applicable): Other (see Work Schedule)Company Trade Name:Merck Nearest Major Market: Harrisonburg Nearest Secondary Market: Virginia Job Segment: Pharmaceutical, Animal Health, ERP, Law, Quality Assurance, Science, Veterinary, Technology, Legal


Elkton, VA, US

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