Quality Scientist - Investigator

MilliporeSigma; St. Louis (MO); On-site; USD 61,000 - 92,000; Full time

Benefits offered by this job

Health insurance

PTO (Paid time off)

Retirement contributions

Job summary

MilliporeSigma in St. Louis, MO is seeking a Quality Control Scientist to lead investigations (OOS/OOT) and CAPA programs under GMP guidelines. You will review data, author procedures, and collaborate with cross-functional teams to ensure product quality.

The role requires strong technical and communication skills, familiarity with TrackWise/LIMS, and experience in a cGMP lab environment. This position reports to QC management and offers a competitive salary.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a life science discipline with 5+ years of experience in a cGMP testing laboratory environment
• OR
• Associate degree in Chemistry, Biochemistry, Biology, or a life science discipline with 10+ years of experience working in a cGMP laboratory environment

Responsibilities

• Manage and lead OOS, OOT, deviation, and CAPA investigations, including root cause analysis using tools such as 5 Whys and Fishbone diagrams and determination of corrective and preventive actions
• Interview QC personnel and collaborate with customers/clients, laboratory analysts, data reviewers, Manufacturing, Quality Assurance, Packaging, and Development to identify root causes and complete investigation reports in TrackWise
• Monitor and report metrics and trends related to non-conformances, CAPAs, quality events, and invalids
• Write, review, and approve operating procedures, specifications, OOS/OOT trend reports, and other QC-controlled documents
• Support analytical data review and quality review of documentation and processes for compliance with cGMP, internal procedures, and specifications
• Perform routine process audits and gap analyses while maintaining compliance with company policies, regulatory requirements, quality standards, safety policies, and cGMP requirements
• Perform additional duties as assigned by QC management

Skills

Root cause analysis

CAPA management

OOS/OOT investigations

Documentation review

Communication skills

Education

Bachelor’s degree in Chemistry/related field

Associate degree in Chemistry/related field

Tools

TrackWise

LIMS

SAP

Excel

PowerPoint

Falcon/Veeva

Job 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

The Quality Control Scientist at MilliporeSigma in St. Louis, MO (Cherokee) supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice (GMP) guidelines (ICH Q7), raw materials and drug products. In this role, you will lead OOS, OOT, and deviation investigations associated with release, stability, and in-process samples, as well as manage CAPA projects, effectiveness checks, and change controls. This position reports to the Senior QC Supervisor.

• Manage and lead OOS, OOT, deviation, and CAPA investigations, including root cause analysis using tools such as 5 Whys and Fishbone diagrams and determination of corrective and preventive actions
• Interview QC personnel and collaborate with customers/clients, laboratory analysts, data reviewers, Manufacturing, Quality Assurance, Packaging, and Development to identify root causes and complete investigation reports in TrackWise
• Monitor and report metrics and trends related to non-conformances, CAPAs, quality events, and invalids
• Write, review, and approve operating procedures, specifications, OOS/OOT trend reports, and other QC-controlled documents
• Support analytical data review and quality review of documentation and processes for compliance with cGMP, internal procedures, and specifications
• Perform routine process audits and gap analyses while maintaining compliance with company policies, regulatory requirements, quality standards, safety policies, and cGMP requirements
• Perform additional duties as assigned by QC management

Who You Are

Minimum Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a life science discipline with 5+ years of experience in a cGMP testing laboratory environment

OR

• Associate degree in Chemistry, Biochemistry, Biology, or a life science discipline with 10+ years of experience working in a cGMP laboratory environment

Preferred Qualifications

• 5+ years of experience in the pharmaceutical, biopharmaceutical, or related industry, with knowledge of API manufacturing and testing
• Knowledge of 21 CFR 210, ICH Q7, GMP, FDA, ICH, OSHA, GDP, data integrity, and ALCOA principles
• Experience with OOS/OOT investigations, CAPA, non-conformance deviations, and technical documentation and reports
• Experience with Falcon/Veeva, Chromeleon, LIMS, SAP, Word, Excel, and PowerPoint
• Experience with Antibody Drug Conjugates (ADC)
• Strong technical, communication, customer interface, project management, decision-making, and organizational skills with the ability to work effectively in a team and independently with minimal supervision

Salary range for this position: $61,100 - $91,700 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.

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.