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System One (Biologics/cGMP) Quality Analyst 2 in Exton, Pennsylvania

Job Title: Quality Analyst

Location: Exton, PA

Type: Contract

Overview

Join a pharmaceutical company operating globally in terms of R&D, manufacturing and marketing, with a strong focus on prescription medicines.

Responsibilities

  • The QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses 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.

    Requirements

    Knowledge/Skills/Abilities Required

    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

    Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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