QC Scientist II

Job Summary

Responsibilities

• Perform routine and moderately complex microbiological testing, including Bioburden, Bacterial Endotoxin, Particulate Matter, and Sterility assays.
• Identify, report, and troubleshoot out-of-specification (OOS) or unexpected analytical results following proper compliance protocols.
• Maintain, calibrate, and troubleshoot standard microbiology lab instrumentation.
• Write and revise SOPs, test methods, and instructional documentation while ensuring strict cGMP, cGLP, and safety adherence.
• Accurately document analytical results in lab systems (LIMS) and assist with regulatory document preparation.

Qualifications

• Required: Bachelor's degree in Biology or Chemistry (or an Associate degree in Biotechnology/Science with relevant pharmaceutical lab experience).
• 3+ years of experience in a Pharmaceutical Microbiology laboratory.
• Strong working knowledge of qualitative/quantitative microbiological test methods, cGMP guidelines, and regulatory requirements.
• Demonstrated ability to write SOPs, technical procedures, and method reports.

Preferred Experience

• Experience with LIMS, Trackwise, or Documentum software.
• Prior experience as a technical reviewer or qualified checker.

Skills

• Biology
• Chemistry
• Microbiology
• Laboratory Information Management Systems (LIMS)
• Good Laboratory Practices (GLP)
• Good Manufacturing Practices (GMP)
• Quality Control (QC)

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term Disability
• 401K Plan