Quality Specialist III

3 weeks ago

Rockville, United States MilliporeSigma Full time

This is a 6-8 month contract to hire opportunity


Schedule: M-F 8am-5pm


Pay: $35-38/hr (depending on experience)

First 2-3 months will be 100% onsite. Afterwards, will move to hybrid schedule (at least 3 days onsite).


Who We Are:

A leader in the life sciences. We aim to solve the toughest problems in the industry by collaborating with the global scientific community, and through that help increase access to health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies, and services. We are dedicated to making research and biotech production simpler, faster, and more successful. ​At MilliporeSigma, we are with our customers at every step of the drug development process, shaping the possibilities for tomorrow.


The BioReliance® contract testing portfolio provides best-in-class biosafety testing and analytical development methods for both traditional and novel therapies. This work is critical to ensure the safety of medicines. Currently, about 800 employees work at the Rockville site.


Your Role:

At MilliporeSigma, as the Quality Assurance Specialist 3, youwill perform a variety of tasks within the Quality Assurance department including investigations, deviations, and regulated documentation.

  • Review and approve RCA analysis for robustness and accuracy and/or Perform robust RCA using various RCA tools.
  • Act as the Subject Matter Expert for RCA
  • Train and/or provide peer mentorship in the rootcause Investigative Process and techniques.
  • Analyze and evaluate information captured through investigations, communicate findings and recommendations.
  • Review and approve OOS, trend, critical-impact deviations and lower impact deviations.
  • Conduct trend analysis for deviations
  • Review / approve applicable CAPA records and conduct Effectiveness checks.
  • Communicate effectively with internal stakeholders and external clients to represent quality and company.
  • Review and approve change control (GCC) records.
  • Train Quality Specialists and/or Operations teams on quality topics.
  • Author, review and approve standard operating procedures (SOPs), quality policy documents, and laboratory / batch records.
  • Act as Quality SME during regulatory inspections and customer audits for areas of expertise.
  • Review and approve assay validation documentation and new GxP service documentation.
  • Review and approve manufacturing documentation including: technical specification, production records, environmental monitoring trends.
  • Negotiate terms of quality agreements for suppliers and customers.
  • Assist supervisors and managers with team workload assignments.
  • Participate on interview panel for prospective QA team candidates.
  • Lead and/or participate in customer and/or supplier meetings to discuss audit observations, investigations, or negotiate quality agreements.
  • Conduct commission inspections for current, new or renovated laboratories.
  • Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
  • Review and approve validation files for systems.
  • Perform risk assessment using various methodologies.


Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, etc.).
  • 4+ years’ experience in a Quality role GxP environment.
  • 1+ years’ demonstrable experience on investigative process and techniques in a Quality role.

Preferred Qualifications:

  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
  • Experience with reviewing and approving CAPA records, Effectiveness checks and GCC records.
  • Excellent communication and interpersonal skills.
  • Open-minded, flexible and works with agility.


Millipore Sigma 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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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