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Quality Specialist 3

Company: Merck
Location: Rockville
Posted on: May 3, 2021

Job Description:

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.Your Role:The Quality Specialist III will perform a variety of tasks as part of the Quality team. They will constructively interact and communicate with employees in various settings; Have an understanding of laboratory quality assurance principles to ISO 17025; Independently host client visits and regulatory inspections; Lead and assist in planning facility audits; Perform vendor/subcontractor audits; Provide training and guidance to QAU personnel and others as needed; Lead and participate in departmental business, process, or general regulatory projects.In addition, they will have an excellent understanding of GLPs for FDA, EPA and applicable international regulations; Excellent understanding of complex regulatory requirements and intent; Assure the protocol requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies to evaluate regulatory compliance; Plan, conduct and report study-specific laboratory inspections to assess compliance with GLP regulations/industry standards; Assure QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and eventually archived, as appropriate; Identify regulatory compliance issues and provide regulatory support to departments; and may act as backup to the supervisor or manager. Travel as deemed necessary, up to 25%.Minimum Qualifications:* Bachelor's degree in a scientific discipline (i.e. Biology, Chemistry, etc.) with 4+ years' experience auditing in a GLP facility - OR -* Associate's degree in a scientific discipline (i.e. Biology, Chemistry, etc.) with 6+ years' experience auditing in a GLP facilityPreferred Qualifications:* Experience in conducting detailed external and internal audits* RQAP-GLP, or other applicable certification or registration* Excellent interpersonal and verbal/written communication skills with the ability to interact with all levels of management and Study PersonnelRSRMSWhat we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious? Apply and find more information at The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Keywords: Merck, Rockville , Quality Specialist 3, Other , Rockville, Maryland

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