Quality Specialist I

Posted 14 Mar 2019

Rockville, Maryland - United States

Req Id 186777

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. EMD Performance Materials is a business of Merck KGaA, Darmstadt, Germany.
 


Your Role:

The scope of this individual contributor position within the US Biologics Quality Assurance department includes influence and impact within QA and across a variety of operations departments regarding GXP compliance.
 

ESSENTIAL JOB FUNCTIONS

  • Reviews quality records/documents and conducts inspections, as assigned, for compliance requirements
  • Interacts with other departments to ensure compliance with internal procedures and FDA regulations
  • Demonstrates verifiable turnaround times
  • Participates in projects, as assigned
  • Normally receives general instructions on routine work and on new assignments
  • Also refer to attached department-specific job functions, as applicable

 

DEPARTMENT-SPECIFIC JOB FUNCTIONS

  • Review assay data, protocols, reports, technical specifications, certificates of analysis, RIRs, Cell banking Production Records for compliance requirements.
  • Review lab records, batch records, SOPs and other documents for auditing requirements.
  • Audits routine assays
  • Conducts Systems Inspections and In-Process Inspections
  • Review and approve deviation records

 

 

Who You Are:

Basic Qualifications:

  • Bachelor of Science Degree in Biology, Chemistry, or other Science or Technical discipline
  • 6 months + experience working in Quality Assurance or within a GXP environment.
  • Introductory to working knowledge of FDA regulations (cGMP, GLP, Part 11)

 

Preferred Qualifications:

  • Working knowledge of good documentation practices
  • Good oral, written communication and interpersonal skills required

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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