Job Details

Quality Associate Scientist - Microbiology 2nd Shift

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. Duties include:

• Shift: Monday?Friday 2pm?10:30pm.


• Maintain written records in accordance with cGMP and company procedures.


• Improve and execute processes in an ICHQ7 environment.


• Assist with OOS/OOT investigations and root cause analysis.


• Interact with production and laboratory personnel to ensure adequate communication and feedback for quality?related services to internal customers.


• Maintain and update relevant Ops.

Minimum Qualifications:

• Bachelors Degree in Biology, Chemistry, or other Life Science discipline.


• 1+ years of QC lab experience, specifically in Bioburden (USP), Growth Promotion Testing, and Endotoxin analysis.

Preferred Qualifications:

• Knowledge of aseptic technique and practices.


• Knowledge of SOPs, cGMPs, GLP, GDP and quality control processes.


• Familiar with basic scientific/regulatory principles such as ICH Q7, 21CFR210/211, USP and EP.


• Excellent written and verbal communication skills.


• Work well independently and foster collaboration and teamwork.


• Strong attention to detail and organizational skills.


• Good problem?solving and time management skills.


• Current API knowledge and/or experience.


• 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.

Pay Range: $23.00$42.00 per hour. Benefits include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.