Title: Senior Environmental Monitoring Specialist - QC, Aseptic Processing
Location: Greater Boston Area, MA (Hybrid 5 days onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
Join a Quality Control Microbiology team supporting critical Environmental Monitoring (EM) and Utilities Monitoring (UM) activities in a regulated manufacturing environment. This role serves as a technical SME supporting microbiological testing, contamination control, investigations, and compliance-driven quality operations.
Key Responsibilities
- Provide technical support for Environmental Monitoring (EM) and Utilities Monitoring (UM) activities within QC Microbiology.
- Perform/support microbiological testing including Bioburden, Endotoxin, Sterility, Gram Stain, and Microbial Identification.
- Operate microbiology instrumentation including Vitek, Endosafe, BacT, MALDI-TOF, and Isolator.
- Lead/support OOS/OOT investigations, deviation management, and CAPA implementation related to microbiological methods.
- Prepare EM/UM trend reports, technical documentation, and support laboratory inspections/audits.
- Partner with cross-functional teams supporting manufacturing quality and compliance initiatives.
Qualifications
- 7+ years of Microbiology experience in Biotechnology and/or Cell & Gene Therapy environments.
- Hands-on experience in Aseptic Processing, Contamination Control, and GMP manufacturing environments.
- Strong knowledge of Environmental Monitoring, Utilities Monitoring, Sterility, Endotoxin, Bioburden, and microbiological testing methodologies.
- Experience with LIMS, Veeva, and electronic quality management systems.
- Bachelor’s degree in Microbiology or related field.
Compensation (MA Pay Transparency):
- Estimated hourly range: $60–$65/hr (W-2).
- Final rate within this range will be based on skills, experience, and interview results.