What are the responsibilities and job description for the QC Microbiology Analyst position at IT Solutions LLC?
Duties :
- Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
- Perform environmental monitoring of cleanroom suites and laboratory areas as required.
- Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.
- Support routine QC operations, including but not limited to : instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
- Implement corrective actions and preventive actions (CAPAs).
- Participate in facility qualification activities for microbiological testing and environmental monitoring.
- Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
- Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
- Undertake any other duties as required.
Skills :
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.