Quality Control Chemist i - COllabera : Job Details

Quality Control Chemist i

COllabera

Job Location : Frederick,MD, USA

Posted on : 2025-02-12T19:20:43Z

Job Description :

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  • Quality Control Chemist i Contract: Frederick, Maryland, US Salary Range: 28.00 - 31.00 | Per Hour Job Code: 349790 End Date: 2025-03-07 Days Left: 24 days, 2 hours left Apply To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - email your updated resume at Email - [email protected] or give me a call at (425) ###-####. Thank you! Pay Range - $28 to $31/hr. (negotiable)Job Description:Job Roles & Responsibilities:
    • Perform testing of raw materials, intermediates and final products by following analytical methods: Cell-based bioassays, Flow Cytometry, ELISA and qPCR assays.
    • Work with internal and external resources to maintain lab in an optimal state.
    • Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
    • Supply information to support generation of CoAs for product release.
    • Maintains laboratory instruments for calibration and routine maintenance
    • Author or revise SOPs, qualification/validation protocols and reports.
    • Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
    • Provide updates at daily and weekly meetings.
    • Monitor the GMP systems currently in place to ensure compliance with documented policies.
    • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
    • Gather metric information for use in continuous improvement of areas of responsibility.
    • Perform other duties as required.
    Basic Qualifications:
    • Bachelor's Degree OR
    • AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience OR
    • High School Degree and 3+ years' experience in biotechnology or related field and Quality Control experience
    Preferred Qualifications:
    • Strong knowledge of GMP, SOPs and quality control processes.
    • Identifying, writing, evaluating, and closing OOS's and investigations.
    • Proficient in MS Word, Excel, PowerPoint and other applications.
    • Strong written and verbal communication skills.
    • Ability to communicate and work independently with scientific/technical personnel.
    • Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
    • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
    • Preferred: Experience in the biotech and/or pharmaceutical industry.
    Job Requirement
    • Quality Control Chemist
    • raw materials
    • Cell-based bioassays
    • Flow Cytometry
    • ELISA
    • PCR
    • qPCR
    • biotechnology
    • GMP
    • GLP
    • SOPs
    • ELISA
    • pharmaceutical
    • Biology
    • Biological Sciences
    • Molecular Biology
    • Cellular Biology
    • Biochemistry
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