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QC Analyst I
This QC Microbiology Analyst I reports to Tuesday- Saturday 8am-5pm.
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.
Work is closely supervised. Follows specific, detailed instructions.
Contributions are usually limited to task-related activities. Errors do not typically have a major effect on the organization.
Specific QC Focus Areas:
Product Testing: Area focuses on techniques such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays.
Raw Materials: Area focuses on techniques such as wet chemistry compendial testing, Raman, NIR, titration assays, gas testing.
EM/Microbiology: Area focuses on techniques such as bioburden, endotoxin testing, growth promotion studies, environmental monitoring sampling and testing, microbial identifications.
- 60% of Time: Testing Execution
- 30% of Time: 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)
- 10% of Time: Compliance and quality systems (SOP revisions, input to quality systems records)
- Normally requires a bachelor’s degree and a minimum of 0-2 years related experience.
- (Science related degree is preferred)
- Additional Specific Experience: None
- Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
- MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
- 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.
- Contacts are primarily with immediate supervisor, and other personnel in the section or group.
Other Job Requirements:
- Limited to no travel expected.
- The following physical abilities are required in order to fulfill the job duties:
- Repetitive bending and reaching to setup and break-down equipment
- Ability to work around chemicals
- Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
- Ability to walk and stand for periods of time
*This post excludes CO applicants*