Senior Associate Quality Scientist - Microbiology- 2nd shift
About The Position
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)
- Strong knowledge of SOPs, GMP, GLP, GDP and quality control processes
- Strong knowledge of aseptic technique and practices
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
- 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
- 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
- microbiology related analysis including but not limited to: in-process, drug substance, raw material and water sample endotoxin analysis
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
