Job Title: QC Analyst
Location: Millburn, NJ (Onsite)
Job Summary:
The Quality Control Analyst is responsible for performing chemical, microbiological, and radiological testing of raw materials, intermediates, and finished radiolabeled pharmaceutical products. This role ensures compliance with GMP, FDA, and radiation safety regulations, supporting the release of high-quality, sterile, and safe therapeutic products.
Key Responsibilities:
• Conduct routine and non-routine testing of radiolabeled compounds, sterile drug products, and packaging components.
• Perform chemical and microbiological assays.
• Ensure compliance with radiation safety protocols.
• Maintain and calibrate analytical instruments and laboratory equipment.
• Document test results accurately in accordance with GDP and regulatory standards.
• Support investigations (OOS, deviations, CAPAs).
• Maintain compliance with GLP, GMP, and company SOPs.
Qualifications:
• Bachelor’s degree in Chemistry, Biology, or related field.
• 2+ years of experience in pharmaceutical QC.
• Experience with analytical instrumentation and sterile testing methods.
Job Posting - Fieldglass:
• Strong attention to detail, documentation skills, and regulatory knowledge.
• Ability to work in a fast-paced, highly regulated environment.
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