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cGMP Quality Assurance Specialist

2 months ago

Exton, Pennsylvania, United States Lenmar Consulting Inc. Full time
Position Overview:

The Quality Control Analyst will be responsible for ensuring compliance with cGMP standards in the quality control processes. This role requires a solid educational background and relevant experience in the biopharmaceutical industry.

Qualifications:
  • Bachelor’s degree in biological or chemical sciences or a related field.
  • A minimum of 2-4 years of experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department within a regulated industry.
  • Proficient understanding of QC testing principles, concepts, and practices specific to protein biopharmaceuticals.
  • Practical experience with at least two analytical techniques, including HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, for recombinant protein analysis.
  • Familiarity with GxP requirements and ICH/FDA/EMA regulatory guidelines.
  • Strong problem-solving skills to identify and investigate assay and equipment issues.
  • Excellent command of English, with strong written and interpersonal communication abilities.
  • A collaborative team player capable of thriving in a dynamic, hands-on environment.

Physical Requirements:
Ability to handle laboratory equipment, chemicals, and biological materials safely.

Additional Information:
All personal information will be maintained confidentially in accordance with EEO guidelines.