Sr.Associate Scientist

The Senior Associate Quality Scientist (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.3+ 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 , USP 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.Familiar with basic scientific/regulatory principles.Excellent written and verbal communication skills.Capacity to work independently.Ability to simultaneously manage multiple tasks/priorities good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software.Strong problem-solving and time management skills.