Quality Assurance Specialist II

Posted 20 Nov 2019

Rockville, Maryland - United States

Req Id 200333

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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 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.  The individual performs a variety of tasks in support of specific areas of the QA Audits group within the Quality Assurance department. 

 

  • 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 little to no instructions on routine work and general information on new assignments.
  • Capable of making quality related decisions and provide guidance in areas of expertise
  • Also refer to 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 custom and routine assays, and/or validation documents for assays, equipment, spreadsheets and systems.
  • Conducts Systems Inspections and In-Process Inspections.
  • Review and approve deviation records.
  • May attend meetings as a QA representative, as needed.

 

Who you are:

Minimum Qualifications:

  • Bachelor’s degree in a scientific or technical discipline (i.e. Biology, Chemistry, etc.)
  • 2 + years of experience working in Quality Assurance

 

Preferred Qualifications:

  • Proficient knowledge of U.S. FDA regulations and European (EU) regulations (cGMP, GLP, Part 11, Data Integrity)
  • Advanced working knowledge of Good Documentation Practices
  • Strong oral and written communication and interpersonal skills required 

 

RSRMS


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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