QC Scientist II

St. Louis, MO – Biologics Division

About the role

As the QC MICRO Investigation Writer II, you will operate in a high-throughput environment, completing investigations on behalf of the QC Micro and EM groups. You will lead multiple investigations simultaneously, ensuring on-time completion through dedication, tenacity, and relationship building with partners in QA and various testing groups. This role involves maintaining a steady record closure rate while handling moderate complexity investigations, assisting junior investigators, and participating in QC compliance activities related to audits and continuous improvement.

Responsibilities

• Stay current with training in Success Factors and Thermo Fisher University
• Conduct RAPID meetings with QA and QC staff as needed
• Use TrackWise software to author investigations
• Ensure compliance-related deliverables, including:
  • Audit support and observation response
  • Presentations to senior management and site leadership
  • Generating trend reports to identify organizational weaknesses and suggest improvements
• Support compliance culture initiatives and assist in implementing changes
• Develop the team through proactive and reactive training creation/delivery
• Assist with developing tools and resources to improve the investigative process
• Support Scientist I investigators when needed
• Average 3-4 deviation/OOS/CAPA record closures per month, based on complexity
• Complete overdue assessments and file record extensions as required
• Author/revise SOPs (limited)
• Assist with formulating continuous improvement strategies and timelines
• Perform other job duties as assigned

Requirements

• High School Diploma required; Bachelor’s degree in a science-related field is a plus but not required
• 3 or more years working in a GMP-regulated environment or Quality Role (QA or QC) preferred
• 2 or more years as an investigation, CAPA, and deviation writer preferred
• TrackWise and TapRooT experience is preferred
• Knowledge of GMP regulations, Good Laboratory Practices (GLP), and Good Documentation Practices (GDP)
• Able to read, write, and communicate in English
• Proficient in standard computer programs such as SmartSheet, PowerBI, MS Excel, Word, and PowerPoint
• Ability to inspire innovation and team effectiveness
• Adaptability to evolving environments and varied internal customer needs
• Strong computer, scientific, and organizational skills
• Strong communication skills, including active listening, facilitation, and escalation
• Enjoys collaborative efforts both internal and external to the department

Environmental Conditions

• Office-based role with extended periods of sitting and desk/meeting time
• Wear gloves and other PPE to enter laboratory spaces

Benefits

• Competitive remuneration and annual incentive plan bonus
• Healthcare and a range of employee benefits
• Employment with an innovative, forward-thinking organization
• Career and development prospects within an exciting company culture that values integrity, intensity, involvement, and innovation

Relocation assistance is not provided. Must be legally authorized to work in the United States now and in the future without sponsorship. Must pass a comprehensive background check, including drug screening.