Senior Associate Quality Scientist - Microbiology- 2nd shift
About The Position
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/Senior 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. This position is fully onsite. Job duties 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
Requirements
- Bachelor’s Degree in Biology, Chemistry, Biochemistry or other Life Science discipline
- 1+ years of QC lab experience, specifically in endotoxin analysis (chromogenic, turbidimetric and gel-clot methods)
Nice To Haves
- Current API knowledge and/or experience
- Familiar with basic scientific/regulatory principles
- Excellent written and verbal communication skills
- Capacity to work independently
- Fosters collaboration and teamwork
- Good problem-solving and time management skills
- Strong attention to detail and organizational skills
- Strong knowledge of SOPs, GMP, GLP, GDP and quality control processes
- Knowledge and understanding of endotoxin testing, LER/hold time studies; verification testing
- Experience with ICH Q7, 21CFR210, and applicable USP and EP requirements
- Experience writing technical documents and reports
- Strong 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
Responsibilities
- 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
Benefits
- health insurance
- paid time off (PTO)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
