Senior Associate Quality Scientist - Microbiology- 2nd shift

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Merck Group seeks a Senior Associate Quality Scientist for Microbiology on the 2nd shift in St. Louis, onsite. The role covers microbiology analysis including endotoxin testing across in-process, drug substance, raw materials and water samples, with responsibility for cGMP records and supporting OOS/OOT investigations while collaborating with production and lab teams under ICH Q7. Requirements: bachelor’s in biology, chemistry or related life science and at least 1 year of QC endotoxin experience (chromogenic, turbidimetric or gel-clot); strong SOP/GMP/GLP knowledge; excellent communication; ability to work independently and with others. Pay range $23-$36 hourly; sponsorship not offered. Tips: tailor your resume to endotoxin testing and OOS investigations, highlight problem solving, documentation control, and ICH Q7/GMP experience, and confirm US work eligibility and 2 pm to 10:30 pm availability.

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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

Who You Are

Minimum Qualifications:

• 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)

Preferred Qualifications:

• 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

RSREMD

• Pay Range for this position: $23.00-$36.00.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO),

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