Demo

Quality Assurance Specialist 3 - Customer Support

Merck Group
Rockville, MD Full Time
POSTED ON 2/25/2025
AVAILABLE BEFORE 5/18/2025

Work Location : Rockville, Maryland

Shift :

Department : LS-LS-TQOC US PC Quality

Recruiter : Genie Hooper

This information is for internals only. Please do not share outside of the organization.

Your Role

At MilliporeSigma as the Quality Specialist 3 - Customer Support, you will perform a variety of tasks within the Quality Assurance department focusing on providing high customer excellence for external customers.

  • Collaborate with internal and external customers to rapidly resolve quality concerns and identify corrective and preventative actions.
  • Serves as escalation point for external customers.
  • Act as the quality internal point of contact for key quality related issues.
  • Assist on aligning on key customer quality procedural differences to minimize future roadblocks.
  • Map & assess event trends across labs impacting customers to drive internal remediation plan / strategy.
  • Assist in driving the identification of key customer risks & lead on solid mitigation plans through customer Quality improvement plans (C-QIP).
  • Drive the timely conduct of major customer investigations from events, OOS, complaints and / or data audits, as well as drive effective implementation of key CAPA with significant customer impact.
  • Review and approve deviations / OOS records and CAPAs.
  • Perform data and trend analysis, report metrics to site and global management.
  • Lead and / or provide support for client regulatory submissions and client audits.
  • Review and approve client quality agreements.
  • Provide guidance and / or training for other members of the quality assurance team.
  • Lead and / or provide support for regulatory inspections.
  • Lead and / or participate on global quality improvement project teams.
  • Lead and / or participate in projects as global QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.

Who You Are

Minimum Qualifications :

  • Bachelor's Degree in scientific field (e.g., Biology, Chemistry, Biochemistry, etc.)
  • 6 years' of experience in Quality field within a GxP environment
  • 3 years' experience of quality improvement and support of customers in a services environment.
  • Preferred Qualifications :

  • Strong relationship building and collaboration, ability to drive and manage change.
  • Acts ethically and ensures quality of own work and that of others.
  • Collaborates with various teams including external customers to identify and implement corrective actions and improvements.
  • Applies technology to drive digitalization, improve quality and increase customer value.
  • Works with agility and drives and implements change on local and global scales.
  • Expert knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
  • Excellent communication and facilitation skills (ability to lead internal and external meetings, demonstrated ability to bring consensus among diverse cross-functional teams and external customers).
  • Pay range for this position : $70,500 - $118,300

    Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors. This role may offer the following benefits : medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses

    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.

    Salary : $70,500 - $118,300

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