The incumbent will join the QC team to perform duties as required within the Quality Control testing and support operations.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Performs all routine QC assay analysis not limited to Bioburden, Endotoxin Testing, CFU, Water collection, Growth promotion etc.
- Performs Environmental Monitoring, Reviews EM test data, EM Trend Report and Remediation.
- Participate in the validation of HVAC, Methods and Processes.
- Conduct data entry & trend analysis of data.
- Participate and perform special studies & projects assigned to the Quality Control Laboratory.
- Performs autoclaving and maintenance of all QC Equipment and Housekeeping associated with the lab.
- Order, receive & release QC Media, buffer solutions and supplies.
- Perform peer review of all QC Laboratory data as applicable.
- Follow proper safety measures and policies of the lab while working in the
- Participate in investigations for OOS test results and initiates investigation using the Trackwise system.
- Write, Revise and Review QC protocols and reports as needed.
- Write, review and/or revise QC SOPs as needed.
- Assists in the performance and qualification of other analysts on QC assays that they are a subject matter expert on.
- Perform tracking of equipment needing calibration.
- Perform Microbial isolate qualification, processing and identifications as needed.
- Initiate QC Specifications, Bill of Test, and Certifications of Testing as needed.
- Initiate and document stability testing program for products undergoing stability testing.
QUALIFICATIONS AND REQUIREMENTS:
Familiarity with cGMP and computer skills a plus.
Education Requirements: BS in Microbiology, Biology, Cell Biology; or equivalent experience with 5-7 years experience or MS in Microbiology, Biology, Cell Biology; or equivalent experience with over 2 years experience in a pharmaceutical or biotech environment.
Aeras is an Equal Opportunity Employer. M/F/D/V
Indeed - 22 months ago
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Aeras is constantly producing new constructs that will also be made available following phenotypic, genotypic and stability...