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Analytical Quality Control Specialist

2 months ago

Exton, Pennsylvania, United States Integrated Resources, Inc ( IRI ) Full time

Position Overview:

The Quality Control Analyst 2 plays a vital role in ensuring the operational success by delivering precise, GxP-compliant evaluations of clinical biopharmaceutical products. This position also involves participation in assay qualification and validation initiatives.

Given that biopharmaceutical manufacturing processes often exceed $1 million and can escalate significantly for larger phase 3 projects, along with stability studies costing several hundred thousand dollars, this role is crucial in guaranteeing that release and stability testing yields accurate results without delays or compliance challenges.

The individual will be responsible for maintaining the biochemistry laboratory systems, assisting in the training of fellow analysts, ensuring the upkeep of SOPs and related documentation, and fostering a systematic and efficient laboratory environment.

Educational Requirements:

A Bachelor’s degree in biological or chemical sciences or a related field is required.

Experience, Knowledge & Skills:

• A minimum of 2-4 years of relevant experience in a cGMP Quality Control, analytical development, analytical transfer, or validation department within an FDA-regulated sector.

• Familiarity with the principles, concepts, and practices involved in QC testing of protein biopharmaceuticals.

• Practical experience with at least two analytical techniques, such as HPLC, capillary electrophoresis, ELISA, or SDS-PAGE, utilized for the analysis of recombinant proteins.

• Understanding of GxP standards and ICH/FDA/EMA regulations.

• Capability to identify and assist in the investigation of assay and equipment issues.

• Proficiency in English with strong written communication skills; excellent interpersonal abilities.

• A collaborative team player who thrives in a hands-on, dynamic environment.

Physical Requirements:

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