Quality Control Microbiology Analyst II
Employment Type: Full-Time
Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with supervision. Solve routine problems of limited scope and complexity following established policies and procedures. Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Builds stable working relationships internally.
Work is closely supervised. Follows specific, detailed instructions.
Specific QC Focus Areas:
Microbiology: Area focuses on techniques such as bioburden, endotoxin testing, growth promotion studies, environmental monitoring sampling and testing, biological indicator testing, TOC and pH testing.
* Testing execution, QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary) and Compliance and quality systems (SOP revisions, input to quality systems records).
* A bachelor's degree and a minimum of 3-4 years related experience. (Science related degree is preferred)
* Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
* Key Skills: MS Office, LIMS, MODA, Trackwise, compliance and strong science understanding
USA - MA - Lexington - BIO OPS