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Lead Quality Control Specialist

2 months ago

Exton, Pennsylvania, United States Infotree Global Solutions Full time

Position Overview:

Infotree Global Solutions is seeking a Senior Quality Control Analyst to oversee the operations within our biochemistry laboratory. This role is pivotal in ensuring the integrity and compliance of laboratory systems.

Key Responsibilities:

  • Maintain and enhance laboratory systems while ensuring adherence to industry standards.
  • Facilitate training sessions for junior analysts to promote skill development.
  • Assist in the upkeep of Standard Operating Procedures (SOPs) and related documentation.
  • Foster a systematic and efficient laboratory environment.
  • Conduct precise analyses of clinical biopharmaceutical products, ensuring compliance with GxP regulations.
  • Participate actively in assay qualification and validation processes.

Qualifications:

  • A minimum of 2-4 years of experience in a cGMP Quality Control, analytical development, or validation role within a regulated industry.
  • Proficient understanding of QC testing methodologies for protein biopharmaceuticals.
  • Hands-on expertise with at least two analytical techniques, including HPLC, capillary electrophoresis, ELISA, or SDS-PAGE.
  • Familiarity with GxP standards and ICH/FDA/EMA regulations.
  • Strong problem-solving skills to identify and address assay and equipment issues.

If you possess the required qualifications and are looking for a challenging opportunity, we encourage you to consider this position.