Alphanumeric is hiring an ASSOCIATE QC MICROBIOLOGIST
to work in King of Prussia, PA
with one of the largest pharmaceutical companies in the world.
The Microbiologist performs quality testing
for In process and bulk biopharmaceutical ingredients, finished biopharmaceutical products. Reviews and revise SOP's when needed.Key Responsibilities
Knowledge/ Education / Previous Experience Required
- Working knowledge in cGMP and other regulations in order to assure laboratory compliance.
- Report Observations. Revise SOPs and recommend improvement opportunities to maintain compliance with corporate and regulatory guidelines.
- Send Laboratory equipment out for calibration. Review/approve equipment.
- Initiate and resolves quality investigations for excursions relating to routine laboratory testing and equipment calibrations. Supports Change Controls and CAPAs
- Perform routine testing ,documents and reports results while following validated procedures for raw materials, in process samples, utilities / environmental monitoring and validation testing under the assigned direction of the supervisor or designee.
- Complete verification for environmental monitoring, Inprocess samples and utilities.
- Assist with the execution of validation protocols and reports.
- Routinely utilize SAP/MERPs Trackwise and CMX for data entry.
- Complete monthly work orders
- Supports regulatory audits as needed
- B.S. degree in a science field required in Biology, Microbiology or other related science field
- Entry level candidates acceptable
- Good communication skills
- Works well in a team environment as well as ability to work independently.
- Make sound compliant decisions when needed.
- Experience with Excel, Word
- Flexible work schedule
This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII