Quality Specialist I

Posted 08 Apr 2019

Rockville, Maryland - United States

Req Id 190588

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.
 


Your role: The Quality Assurance Unit is responsible for auditing studies at various stages to assure that they are compliant with application regulations. The incumbent performs audits in a scope defined by the manager. He/she understands and interprets the applicable regulations and possesses basic scientific knowledge of the audit scope. The incumbent provides an independent review or audit of data, processes and reports for the assigned audit scope. Leads others in the interpretation of the regulations, and applicable protocols and SOPs.

PHYSICAL ATTRIBUTES

  • Pre-Employment testing requirements
  • PFT and Hep B vaccine in addition to routing physical and blood work at Occupational Health Consultants
  • Physical Requirements (PPE, lifting)
  • Ability to use respirators

ESSENTIAL JOB FUNCTIONS

  • Good understanding of GLP compliance and familiarity with the critical aspects of FDA, EPA, and applicable international regulations.
  • 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.
  • Conduct and report study-specific inspections to assess compliance with GLP regulations and industry standards.
  • Assure QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and eventually archived, as appropriate.
  • An understanding of laboratory quality assurance principles to ISO 17025 and their application as specified in the Quality Manual
  • Constructively interact and communicate with employees at all levels in a compliance setting.
  • Keep QAU and QA Management apprised of compliance issues through frequent updates.

EXPANDED JOB FUNCTIONS

  • Learn to identify regulatory compliance issues and provide regulatory support departments.
  • Learn to assist in handling both client and government inspections and requests.
  • Learn to serve as a liaison with operations departments to support consistent practice and advice.
  • Learn to assist in conducting facility audits
  • Participate in departmental business, procedure, process, or general regulatory projects.
  • Possess good interpersonal and verbal/written communication skills with the ability to interact with all levels of management.
  • Highly motivated and detail oriented with proven organizational skills.
  • Independently determines and develops approach to solutions.
  • Proven experience in auditing or relevant laboratory/facility setting experience.
  • Excellent computer skills in word processing, spreadsheets and database software applications, specifically MS Office (Word, Excel, PowerPoint.)
  • Work with minimal supervision and independently determine corrective actions.

Who you are:

Minimum Qualifications:

  • Bachelor’s Degree in a science field preferred (experience may be considered in lieu of a degree). 

Preferred Qualifications:

  • Working knowledge of a research laboratory
  • Experience auditing in a GLP or GMP facility
  • Proven experience in conducting detailed external and internal audits, desirable.
  • RQAP-GLP, or other applicable certification or registration desirable.

What 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 https://jobs.vibrantm.com

 

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.

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