Quality Assurance Specialist 3 at The businesses of Merck KGaA, Darmstadt, Germany

Rockville, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Dec, 25

Salary

122600.0

Posted On

21 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Root Cause Analysis, FDA Regulations, EU Regulations, Communication Skills, Interpersonal Skills, Trend Analysis, Regulatory Compliance, Training, Documentation, Risk Assessment, Collaboration, Agility, Mentorship, GxP Environment, Change Management

Industry

Pharmaceutical Manufacturing

Description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: At MilliporeSigma, as a Quality Assurance 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. Function as the Subject Matter Expert for RCA and Quality SME during regulatory inspections and customer audits for areas of expertise; Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics. Train and/or provide peer mentorship in the Root Cause Investigative Process and techniques; Train Quality Specialists and/or Operations teams on quality topics. Analyze and evaluate information captured through investigations. Communicate findings and recommendations; Conduct trend analysis for deviations; Review and approve OOS, trend, critical-impact deviations, and lower impact deviations. Author, review, and approve standard operating procedures (SOPs), quality policy documents, laboratory/batch records, GMP part numbers, and other quality records. 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. 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 and assays. Conduct laboratory inspections to include commissioning and/or internal audits. Provide support for client regulatory submissions, client audits and supplier audits. Review and approve client and supplier quality agreements. Provide support for regulatory inspections. 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 within a GxP environment. -OR- Associate Degree in Biology, Chemistry, Engineering, or other scientific field with 6+ years' experience in quality within a GxP or regulated field. -OR- High School Diploma or GED with 8+ years' experience in quality within a GxP or regulated field. Preferred Qualifications: Experience with root cause analysis 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. Pay Range for this position: $76,500-122,600 annually 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. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

Conduct audits and review/approval of regulated documentation. Function as the Subject Matter Expert for RCA and Quality during regulatory inspections and customer audits.