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Form of work
SalaryThe QC Microbiologist II will have several responsibilities in the QC group. The analyst will perform environmental monitoring (EM) for particulates and viable samples in support of cGMP manufacturing. This includes several production suites of EU Grade A to D in a GMP facility that produces biopharmaceuticals (vaccines, biologics, viral vaccines, monoclonal antibodies, etc.). In addition, monitoring of purified water, and compressed gases systems is required. Additional responsibilities may include EM data review and compilation and verification of data, report writing, and trending of data, gowning training, annual gowning qualification and quality record assistance.
Responsibilities:
- Perform environmental monitoring for HVAC (viable air, viable surface, total particulates, personnel monitoring).
- Perform purified water sampling and testing (conductivity, TOC, bioburden).
- Perform entry of data or data verification, as needed into EM database. Assist in generation of quarterly and annual trend reports.
- Participate in visual inspection program of final products as part of fill-finish activities.
- Perform sample log-in, assignment of accession numbers and coordinate shipment of samples to outside test labs.
- Perform microbiological testing such as endotoxin, growth promotion, etc.
- Perform QC Laboratory testing accurately, according to schedule, and as per written procedures. Record all data, observations, and QC results accurately with attention to detail.
- Cross train for production inspection and packaging activities.
- Order and maintain laboratory reagents and supplies.
- Assist or lead quality record completion (OOS, EM investigations, deviations, change control, CAPAs).
- Vaccination in support of upcoming projects.
- Other duties as assigned
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
