Biopharmaceutical Quality Assurance Specialist

2 weeks ago


Exton, Pennsylvania, United States Tech Observer Full time

Position Overview:

The Quality Control Analyst II plays a crucial role in ensuring operational excellence by delivering precise, GxP-compliant evaluations of clinical biopharmaceutical products. This position also involves active participation in assay qualification and validation studies.

Educational Requirements: A Bachelor’s degree in biological or chemical sciences or an equivalent field is required.

Professional Experience:

Candidates should possess a minimum of 2-4 years of relevant experience in a cGMP Quality Control, analytical development, analytical transfer, or validation environment within an FDA-regulated sector.

Familiarity with the principles, concepts, and methodologies related to QC testing of protein biopharmaceuticals is essential.

Technical Skills:

Hands-on expertise with at least two analytical techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, is necessary for the analysis of recombinant proteins.



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