Quality Scientist- QC Investigator
Millipore Corporation

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-POKQC1 Cherokee QC Group 1
Recruiter: Guadalupe Barragan

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

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 guidelines (ICHQ7) and Drug Products. In this role, you will be overseeing and leading out of specification (OOS) and out of trend (OOT) investigations and deviation investigations associated with release, stability, and in-process samples. The position is also accountable for execution and management of quality control CAPA projects, Effectiveness check and change controls. The position reports to Senior QC Supervisor.

• Manage OOS, OOT, Deviations, and CAPAs.
• Lead investigations (OOS, OOT, and Deviations).
• Perform root cause analysis using industry standards such as 5 Why's, Fishbone diagram etc
• Determine relevant corrective and preventative action.
• Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
• Interact with the customer/clients, laboratory analyst, data reviewer, manufacturing, quality assurance, packaging, and development personnel to ensure adequate Root Cause is identified.
• Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA).
• Write, review, and approve Operating Procedures, Specifications, and other QC controlled documents.
• Occasionally support and perform detailed data review for analytical data packets generated by quality control for compliance with cGMP, internal OPs and specifications.
• Write, review, and approve OOS and OOT trend reports.
• Provide trend reports of quality events/invalids.
• Maintain compliance with company policies, regulatory requirements, quality specifications, and safety standards.
• Perform routine audits of processes and gap analysis as needed.
• Perform quality review of documentation and processes Provide trend reports of quality events.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Additional duties assigned by the QC management.

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Biology, or other life science discipline.
• 5+ years of work experience in a cGMP testing laboratory environment.

OR

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

Preferred Qualifications:

• 5+ years of work experience in pharmaceutical, biopharmaceutical, or related industry.
• API manufacturing and testing knowledge and/or experience desired.
• Knowledge of 21CFR210 and ICH Q7.
• Prior involvement in OOS/OOT investigations, CAPA and non-conformance deviations.
• Strong computer skills, including proficiency in Word, Excel, and PowerPoint.
• Outstanding written and verbal communication and customer interface skills.
• Experience writing technical documentation and reports.
• Demonstrate strong technical knowledge.
• Familiar with scientific/regulatory principles.
• Experience with Trackwise, Chromeleon, LIMS and SAP.
• GDP, Data integrity and ALOCA.
• Antibody drug conjugate (ADC) experience.
• Familiar with GMPs, FDA, ICH and OSHA requirements.
• Highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Experience in multi-disciplinary project management, along with strong communication and decision-making skills.

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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