Quality Analyst II
📋 Role Overview & Responsibilities
Description:QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analysis of clinical biopharmaceutical products and by participating in assay qualification and validation studies. Biopharmaceutical manufacturing runs typically cost in excess of 1$ million each and reach many times that for larger, phase 3 campaigns, while stability studies cost several hundred thousand dollars each, and this individual has an important role in ensuring that release and stability testing generates accurate results, without delays or compliance issues. The individual will help maintain the biochemistry laboratory systems, assist in training other analysts, help maintain SOPs and other documents, and promote an orderly and efficient laboratory workplace.
Education: BS in biological or chemical sciences or equivalent
Experience:Minimum of 2-4 yrs 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; good interpersonal skills.Team player who can excel in a "hands-on entrepreneurial environment.Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
Frequently Asked Questions
How do I apply for the Quality Analyst II position at Maxis Clinical Sciences? ▼
Click the “Apply for this Position” button on this page to submit your application directly to Maxis Clinical Sciences without recruitment intermediary fees.
Is this position eligible for remote work or visa sponsorship? ▼
This position is located in Exton, PA with potential relocation and sponsorship assistance depending on candidate qualifications.
Are there any candidate fees on Hirely? ▼
No. Hirely is completely free for candidates. We never charge registration fees or placement fees.
Legitimate employers will never ask you to transfer funds, purchase equipment from unauthorized vendors, or pay application/visa fees. Hirely rigorously monitors listings, but always verify communication is from official corporate email domains.
Learn how to protect yourself against employment fraud →