Sr. Associate Quality Scientist 1

 

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 Microbiologist (QC Microbiology) is responsible for microbiology related analysis specifically including but not limited to: in-process, drug substance, raw material and water sample endotoxin analysis. Job duties include:

 

• 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.
• This position is fully onsite and will be scheduled for second shift, with regular hours of 2pm to 1030pm.  You will be trained on first shift and transitioned to second shift once training is completed.

 

Who you are:

Minimum Qualifications:

 

• Bachelor’s Degree in Biology, Chemistry, or other life science discipline.
• 1+ years of QC lab experience.

 

Preferred Qualifications:

 

• Current API knowledge.
• Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes.

• Knowledge and understanding of endotoxin testing and analysis (chromogenic, turbidimetric and gel-clot methods)

• Understanding of LER/hold time studies and verification testing.

• Experience with ICH Q7, 21CFR210, USP <85>, USP <1085> and EP pharmacopeia requirements.

• Experience writing technical documents and reports.
• Knowledge of aseptic technique and practices.
• Ability to perform minor troubleshooting on microbiological processes and associated laboratory equipment.
• Experience with documentation control: writes, reviews, and approves operating procedures, reports, protocols, and other QC controlled documents.<