Associate I, Quality Control Microbiology, EM & Critical Utilities / SUN- WED

6 Months - likely to go longer

Norwood, MA

Max PR: $38

Shift: Sun-Wed 10am - 8pm

Must Haves:

• BS DEGREE, 6 months to 2 years of work experience
• Overall Scope of Position: This person will be performing environmental monitoring.
• Interview Process: 3, 30 min interviews
• Location: 100% on-site in Norwood
• Shift: Sun-Wed 10am - 8pm (5% shift differential)
• Shift: M-F

Job Summary

In this role, you will perform routine environmental monitoring and critical utility (WFI and Gas) Sampling at manufacturing facilities in support of both Clinical and Commercial Manufacturing Operations.

Job Responsibilities

• Conduct Environmental Monitoring (Routine, In-Process, and EMPQ’s), 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.

Education & Qualifications

• 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.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
• 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.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.