Sigma
Quality Scientist (QC Microbiology)
The 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 analysis. Job duties include: Conduct and lead testing of raw materials and products using a variety of equipment and compendial methodology and non-compendial methods, including analytical and microbiological testing for quality compliance and release. Perform technical review of assays and assist in method development, process improvements and resolves complex technical issues through analytical thinking and troubleshooting using established or advanced technologies. 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. Minimum Qualifications: Bachelor's Degree in Biology, Chemistry, or other Life Science discipline. 5+ years of microbiology experience in a cGMP environment. Preferred Qualifications: API knowledge. Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes. Knowledge and understanding of endotoxin (USP
) and Bioburden (USP ) testing Experience with ICH Q7, 21CFR210, USP and EP. 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.
The 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 analysis. Job duties include: Conduct and lead testing of raw materials and products using a variety of equipment and compendial methodology and non-compendial methods, including analytical and microbiological testing for quality compliance and release. Perform technical review of assays and assist in method development, process improvements and resolves complex technical issues through analytical thinking and troubleshooting using established or advanced technologies. 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. Minimum Qualifications: Bachelor's Degree in Biology, Chemistry, or other Life Science discipline. 5+ years of microbiology experience in a cGMP environment. Preferred Qualifications: API knowledge. Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes. Knowledge and understanding of endotoxin (USP
) and Bioburden (USP ) testing Experience with ICH Q7, 21CFR210, USP and EP. 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.