Quality Assurance Specialist

2 weeks ago


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

Position: Quality Control Analyst

Company: Integrated Resources, Inc (IRI)

Overview:

We are seeking a qualified individual with a solid background in analytical laboratory practices, particularly within the pharmaceutical manufacturing sector. The ideal candidate will have experience in in-process, release, and stability testing utilizing methodologies such as HPLC, ELISA, and capillary gel electrophoresis. Familiarity with PCR techniques is an added advantage.

Key Responsibilities:

  • The Quality Control Analyst will play a crucial role in ensuring the operational success by delivering precise, GxP-compliant evaluations of clinical biopharmaceutical products. This includes involvement in assay qualification and validation processes.
  • As biopharmaceutical manufacturing operations can incur significant costs, the analyst will be pivotal in guaranteeing that release and stability testing yields accurate results, avoiding any delays or compliance issues.
  • The individual will assist in maintaining laboratory systems, contribute to the training of fellow analysts, uphold SOPs and documentation, and foster a well-organized and efficient laboratory environment.

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, or validation department within an FDA-regulated setting.

• Proficient understanding of principles and practices in QC testing of protein biopharmaceuticals.

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

• Familiarity with GxP standards and ICH/FDA/EMA regulations.

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

• Proficient in English with strong written communication and interpersonal skills.

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

• Physical requirements include the handling of laboratory equipment, chemicals, and biological materials.



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