Quality Assurance Specialist 3
Millipore Corporation

Work Location: Rockville, Maryland
Shift:
Department: LS-AS-TQOCA US PC Audits
Recruiter: Genie Hooper

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

Your Role:

At MilliporeSigma, as a Quality Assurance Specialist 3, your tasks will include conducting audits and review/approval of various types of regulated documentation.

• Review and approve RCA analysis for robustness and accuracy and/or perform robust RCA using various RCA tools and act as the Subject Matter Expert for RCA.
• Train and/or provide peer mentorship in the root cause 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 and conduct trend analysis for deviations.
• Review / approve applicable CAPA records and conduct Effectiveness checks.
• Review and approve change control (GCC) records.
• Train Quality Specialists and/or Operations teams on quality topics.
• Provide support for regulatory inspections and for client regulatory submissions.
• Act as Quality SME during regulatory inspections and customer audits for areas of expertise.
• Conduct laboratory inspections to include internal audits and assay methods.
• Author, review and approve standard operating procedures (SOPs), quality policy documents.
• May review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records.
• May 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.
• May review and approve validation files for systems and assays.
• Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics.
• May perform risk assessment using various methodologies.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Biology, Chemistry, Engineering, or other scientific field with 4+ years' experience in Quality Assurance within a GxP environment.
• 1+ years' experience in conducting and/or reviewing root cause analysis and CAPA for deviations and out-of-specification (OOS) results in a Quality Assurance role

Preferred Qualifications:

• Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity).
• Excellent communication and interpersonal skills.
• Ensures quality of own work in an ethical manner.
• Open-minded, flexible and works with agility.
• Meets assigned deadlines.
• Works with cross-functional teams and builds networks within QA and Operations departments.
• Collaborates with various teams to identify and implement improvements.
• Willing to embrace and implement change on a global scale.

$76,500 - $124,600

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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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