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Quality Assurance Specialist

2 months ago

Exton, Pennsylvania, United States Joulé Full time
Job Title:

Quality Analyst 2

Job Summary:

We are seeking a highly skilled Quality Analyst 2 to join our team at Joulé. The successful candidate will be responsible for providing accurate and GxP-compliant analyses of clinical biopharmaceutical products, participating in assay qualification and validation studies, and maintaining the biochemistry laboratory systems.

Responsibilities:
  • Contribute to the success of the operation by providing accurate and GxP-compliant analyses of clinical biopharmaceutical products.
  • Participate in assay qualification and validation studies to ensure the accuracy and reliability of test results.
  • Maintain the biochemistry laboratory systems, including equipment, chemicals, and biological materials.
  • Assist in training other analysts and help maintain SOPs and other documents.
  • Promote an orderly and efficient laboratory workplace.
Requirements:
  • BS in biological or chemical sciences or equivalent.
  • Minimum of 2-4 years working experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department in a FDA-regulated industry.
  • Knowledge of principles, concepts, and practices in QC testing of protein biopharmaceuticals.
  • Hands-on experience with at least two techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, used for analysis of recombinant proteins.
  • Knowledge of GxP requirements and ICH/FDA/EMA guidelines.
  • Ability to identify and help investigate assay and equipment problems.
  • Fluent in English, good written communication skills, and good interpersonal skills.
Benefits:

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.