Quality Control Specialist

2 weeks ago


Exton, Pennsylvania, United States Maxis Clinical Sciences Full time
Job DescriptionPosition Overview:

The Quality Control Specialist will play a crucial role in ensuring the operational success by delivering precise, GxP-compliant evaluations of clinical biopharmaceutical products. This position involves active participation in assay qualification and validation studies.

Given that biopharmaceutical manufacturing processes can exceed $1 million and stability studies can cost several hundred thousand dollars, this role is vital in guaranteeing that release and stability testing yields accurate results without delays or compliance issues.

The individual will be responsible for maintaining the biochemistry laboratory systems, assisting in the training of fellow analysts, ensuring that SOPs and other documentation are up to date, and fostering an organized and efficient laboratory environment.


Essential Knowledge, Skills, and Abilities:
Educational Background:

BS in biological or chemical sciences or an equivalent qualification.

Professional Experience:
  • 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.
  • Understanding of principles, concepts, and practices in QC testing for 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.
  • Familiarity with GxP requirements and ICH/FDA/EMA guidelines.
  • Ability to identify and assist in the investigation of assay and equipment issues.
  • Proficient in English with strong written communication and interpersonal skills.
  • A collaborative team player who thrives in a hands-on, entrepreneurial setting.

Physical Requirements:

Capability to handle laboratory equipment, chemicals, and biological materials.

Company Overview

Maxis Clinical Sciences is a leading provider of comprehensive solutions for Clinical and Digital Services. Recognized in the industry for its integrated research competence center, the company operates globally, offering 24/7 delivery with teams across North America, Europe, and Asia.

Maxis adopts a problem-solving approach that emphasizes building genuine relationships and maintaining steady communication. As a true center of clinical and digital expertise, the company boasts over 200 techno-functional domain experts, each with an average of 12+ years of experience.

Our esteemed service areas that have garnered global recognition include clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, and RWD aggregation and curation services.



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