Quality Control Analyst Job at Infotree Global Solutions, Frederick, MD

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  • Infotree Global Solutions
  • Frederick, MD

Job Description

Position Summary:

We are seeking a highly motivated and detail-oriented Quality Control Analyst to support QC operations in a biopharmaceutical setting. The successful candidate will be responsible for performing analytical testing of raw materials, intermediates, and final drug products in compliance with regulatory and internal quality standards. The ideal candidate will have hands-on experience with cell-based bioassays, flow cytometry, ELISA, and qPCR assays.

Key Responsibilities:

  • Perform routine and non-routine testing of raw materials, in-process samples, and finished products using techniques including:
  • Cell-based bioassays
  • Flow Cytometry
  • ELISA
  • Quantitative PCR (qPCR)
  • Accurately document and review test results following Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
  • Support laboratory investigations related to out-of-specification (OOS) or atypical results, including data review and root cause analysis.
  • Participate in deviation investigations and assist with corrective and preventive actions (CAPAs) related to analytical procedures.
  • Maintain, calibrate, and troubleshoot laboratory instruments and equipment.
  • Assist in the preparation and review of standard operating procedures (SOPs), protocols, and test methods.
  • Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and R&D to support QC deliverables.

Qualifications:

  • 1–3+ years of experience in a GMP-regulated biopharmaceutical QC lab.
  • Hands-on experience with:
  • Cell-based assays (potency or functional assays)
  • Flow cytometry
  • ELISAs
  • qPCR and related nucleic acid-based techniques
  • Familiarity with laboratory investigations, root cause analysis, and deviation documentation.
  • Experience with LIMS or electronic lab notebook (ELN) systems.

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