Quality Control Associate
4 days ago
We are seeking a highly skilled Quality Control Associate to join our team as a Microbiologist. As a key member of our quality control team, you will be responsible for performing routine environmental monitoring and critical utility sampling at our manufacturing facilities in Norwood, Massachusetts.
Key Responsibilities:
- Conduct environmental monitoring (routine, in-process, and EMPQs), WFI sampling, and compressed gas sampling.
- Maintain lab equipment and perform housekeeping tasks.
- Write, revise, and follow SOPs, protocols, and reports.
- Ensure data entry, review, and trending are performed using LIMS.
- Collaborate with internal and external labs for sample coordination and testing.
- Troubleshoot equipment and test methods.
- Support quality systems records such as deviations, change controls, and CAPAs.
- Participate in audits and continuous improvement initiatives.
Requirements:
- STEM degree with 0 years of experience in a GMP QC laboratory setting, focusing on microbiology.
- Hands-on experience with particle counters, viable air samplers, and gas equipment.
- Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP, eQMS).
- Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
- Strong written and oral communication skills and organizational abilities.
- Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
Estimated Salary: $35.25 per hour
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