cGMP Quality Assurance Specialist

2 weeks ago


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

The role of the Quality Control Analyst at Lenmar Consulting Inc. is essential in ensuring the integrity and compliance of our biopharmaceutical products.

Qualifications:
  • A Bachelor’s degree in biological or chemical sciences or a related field.
  • A minimum of 2-4 years of relevant experience in a cGMP Quality Control, analytical development, or validation environment within an FDA-regulated sector.
  • Proficient understanding of QC testing principles and practices specific to protein biopharmaceuticals.
  • Practical experience with at least two analytical techniques, including HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, for the evaluation of recombinant proteins.
  • Familiarity with GxP standards 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 verbal communication abilities; effective interpersonal skills.
  • 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 information will be treated confidentially in accordance with EEO guidelines.

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