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Lead Quality Control Specialist

2 months ago

Exton, Pennsylvania, United States Infotree Global Solutions Full time

Position Overview:

Our esteemed Pharmaceutical partner is seeking a Senior Quality Control Analyst to oversee the biochemistry laboratory operations. This role involves training fellow analysts, ensuring the maintenance of Standard Operating Procedures (SOPs) and related documentation, and fostering a systematic and productive laboratory environment.

Key Responsibilities:

  • Conduct precise, GxP-compliant evaluations of clinical biopharmaceutical products.
  • Engage in assay qualification and validation studies to ensure compliance and quality.

Job Title: Senior Quality Control Analyst

Contract Type: W2 Contract & Onsite Role

Location: Exton, PA

Qualifications:

  • At least 2-4 years of experience in a cGMP Quality Control, analytical development, or validation environment within an FDA-regulated sector.
  • Solid understanding of QC testing principles for protein biopharmaceuticals.
  • Practical experience with two or more analytical techniques, including HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, for recombinant protein analysis.
  • Familiarity with GxP standards and ICH/FDA/EMA regulations.
  • Capability to identify and assist in resolving assay and equipment issues.

If you possess the necessary qualifications and are interested in this opportunity, we encourage you to consider applying.