Job Id
290963
St. Louis, Missouri, United States
Job Type
Full-time
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 Associate Quality Scientist (QC Microbiology) is responsible for microbiology related analysis including but not limited to in-process, drug substance, raw material and water sample endotoxin analysis. Responsibilities and tasks include:

• Shift: Monday-Friday 2pm-10:30pm.
• Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
• Working within various internal departments to improve and execute processes used in an ICHQ7 environment.
• Assisting with OOS/OOT investigations and root cause analysis investigations.
• Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Maintaining and updating relevant Ops.

Who You Are

Minimum Qualifications:

• Bachelor’s Degree in Biology, Chemistry, Biochemistry or other Life Science discipline.

Preferred Qualifications:

• 3+ years of QC lab experience, specifically in endotoxin analysis (chromogenic, turbidimetric and gel-clot methods).
• Knowledge and understanding of endotoxin (USP <85>) and Bioburden (USP<61>) testing.
• Knowledge of analytical testing such as protein concentration.
• Familiar with basic scientific/regulatory principles such ad ICH Q7, 21CFR210/211, USP and EP.
• Excellent written and verbal communication skills.
• Work well independently.
• Fosters collaboration and teamwork.
• Ability to simultaneously manage multiple tasks/priorities Good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.
• Good problem-solving and time management skills.
• Strong attention to detail and organizational skills.
• Current API knowledge and/or experience.
• Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes.
• Experience writing technical documents and reports.
• Knowledge of aseptic technique and practices.
• Ability to perform minor troubleshooting on microbiological processes and associated laboratory equipment.
• Documentation Control: writes, reviews, and approves Operating Procedures, Reports, Protocols and other QC controlled documents.

• Shift: Monday-Friday 2pm-10:30pm.
• Ensuring that suitable written records and work undertaken are kept in accordance with cGMP and company procedures.
• Working within various internal departments to improve and execute processes used in an ICHQ7 environment.
• Assisting with OOS/OOT investigations and root cause analysis investigations.
• Interacting with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
• Maintaining and updating relevant Ops