Senior Associate Quality Scientist - Weekend Shift
About The Position
The Quality Control Microbiology Department supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines, including ICH Q7. The QC Senior Associate Scientist performs a broad range of microbiological analyses with increasing independence and provides reliable laboratory support to internal customers. The role applies sound technical judgment to routine testing, assists with investigations and documentation, and serves as a resource for less experienced team members. The position is located at the 3300 South Second Street facility in St. Louis and works Friday through Monday, 12:00 p.m. to 10:30 p.m.
Requirements
- Bachelor’s degree in Biology, Microbiology, or another Life Science discipline.
- At least 1 year of Quality Control experience.
- At least 2 years of hands-on laboratory experience, including aseptic technique, pipetting, dilutions, calculations, and controlled documentation.
Nice To Haves
- Current API, pharmaceutical, or microbiology Quality Control experience.
- Working knowledge of cGMP, GDP, GLP, ICH Q7, and applicable laboratory procedures.
- Working knowledge of relevant pharmacopeial requirements, including USP <61>, USP <62>, USP <85>, and applicable EP requirements.
- Ability to independently manage routine assignments and communicate issues clearly and promptly.
- Experience with bioburden, endotoxin, microbial limits, growth promotion, microbial identification, biological indicators, or verification studies.
- Experience supporting OOS/OOT, deviation, or root cause investigations.
- Experience writing technical documentation, laboratory reports, protocols, or procedure revisions.
- Good computer skills, including Microsoft Word, Excel, PowerPoint, and laboratory or quality systems.
- Strong attention to detail, organization, time management, problem-solving, and collaboration skills.
Responsibilities
- Independently perform qualified routine microbiological testing of in-process, drug substance, raw material, and water samples in accordance with approved procedures.
- Execute and document testing such as bioburden, endotoxin, microbial limits, growth promotion, microbial identification, biological indicator, and verification testing, as qualified.
- Prepare samples, media, reagents, and materials; perform calculations, dilutions, pipetting, and data review accurately.
- Recognize atypical results and laboratory events, initiate appropriate notifications, and support timely triage and documentation.
- Assist with OOS, OOT, deviation, and root cause investigations by gathering data, evaluating laboratory factors, and completing assigned actions.
- Draft or revise operating procedures, reports, protocols, forms, and other controlled documents with appropriate review.
- Perform minor troubleshooting of methods, equipment, reagents, and test materials within established procedures and escalate when needed.
- Support training and qualification of Associate Scientists and other laboratory personnel on routine methods and good documentation practices.
- Communicate testing status and quality-related information regularly with QC, production, quality assurance, and other internal departments.
- Contribute to continuous improvement, laboratory readiness, and effective execution of work in an ICH Q7 environment.
Benefits
- Health insurance
- Paid time off (PTO)
- Retirement contributions
- Position may be eligible for sales or performance-based bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Senior
