• QC Biochemist II

    Astrix Technology (Chicago, IL)


    QC Biochemist II

     

    Quality Control

    Chicago, IL, US

    Pay Rate Low: 30 | Pay Rate High: 33.65

     

    + Added - 15/04/2025

     

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    Looking for an experienced QC biochemist to continue growing their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry.

     

    + **Pay** : $29-33/hr

    + **Hours:** 1st shift M-F

    + **Terms:** 6 month contract-to-hire

    Essential Duties & Responsibilities

    + Perform analytical testing to support product in-process, release, and stability programs.

    + Demonstrate strong knowledge of **cGMP** , **Quality Systems** , and **ICH/regulatory** guidance.

    + Conduct, compile, and/or review Out of Specification (OOS) lab investigations, deviations, and corrective and preventative action plans.

    + Collaborate with cross-functional teams to advance projects, maintain equipment, and author documents and reports.

    + Train other analysts in laboratory procedures and assays. Participate in internal assessments and audits as required.

    + Perform other functions as assigned.

    + Comply with all company policies and standards.

    REQUIREMENTS** **:

    **Education** :

    + **Bachelor’s degree** in biotechnology, biochemistry, chemistry, or related field with a minimum of **5 years of experience** in a pharmaceutical/biotech QC laboratory.

    + Alternatively, a **Master’s degree** in the above fields with **3 years of experience** in a pharmaceutical/biotech QC laboratory or a **PhD** with a minimum of **2 years of experience** .

    **Experience** :

    + Previous experience in a **cGMP laboratory** .

    + Strong background in **protein chemistry** and experience troubleshooting analytical results.

    + Demonstrated success in writing, revising, and complying with **SOPs** , protocols/reports, and **QC methods** .

    **Special Skills** :

    + Demonstrated expertise with techniques such as **HPLC** , **SDS-PAGE** , **cell-based bioassays** , **capillary electrophoresis** , **ELISA** , and standard compendial assays.

    + Previous experience supporting regulatory inspections (e.g., **PAI** ).

    + Familiarity with preparing **regulatory dossiers** and data packages for interactions with regulatory agencies.

    **Work Environment & Physical Demands** :

    + Some time spent in an office performing administrative tasks such as reading, writing, reviewing, and editing documents.

    + Significant amount of time spent in the laboratory.

    + Must be able to work extended hours or weekends as requested.

    + Must be able to lift at least **25 lbs** .

    + Ability to work under pressure and meet deadlines in a high-paced environment structured to meet ambitious project goals.

    + Some travel may be required. _This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!_ INDMW

     

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.