QC Microbiology Analyst – Weekend Shift, GMP Compliance

Proclinical Staffing

Norton (MA)

On-site

USD 55,000 - 62,000

Full time

2 days ago

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Job summary

Proclinical is seeking a QC Microbiologist to support quality control operations within a pharmaceutical or biotechnology environment. The role requires performing microbiological testing, environmental monitoring, and contributing to regulatory compliance.

Weekend shift availability is required to support operations and maintain quality standards. Responsibilities include raw material, in-process, and product release testing, bioburden and endotoxin analyses, documentation, and continuous

Qualifications

Bachelor's or higher in chemistry, biology, biochemistry, or related field.
Experience in GMP QC in pharma/biotech.
Familiarity with method transfer, lifecycle management preferred.
Strong writing, data analysis, problem-solving, and organizational skills.

Responsibilities

Perform microbiological assays for raw materials, in-process samples, product release and stability studies.
Carry out Bioburden, Endotoxin, and Biotoxin testing.
Conduct environmental monitoring and maintain aseptic technique.
Support weekend lab operations and training records.
Assist with lab equipment maintenance, inventory, and reagents preparation.
Review data as a qualified data reviewer and ensure SOP compliance.
Contribute to updating SOPs, work instructions and test methods.
Support regulatory submissions, inspections, and audits.