Quality Control Chemist

Job Description

Duration: 5 months

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Location: Frederick, MD

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IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete.

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Responsibilities (include but are not limited to):

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• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
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• Work with internal and external resources to maintain lab in an optimal state.
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• 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.
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• Maintains laboratory instruments for calibration and routine maintenance
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• Author or revise SOPs, qualification/validation protocols and reports.
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• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
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• Provide updates at daily and weekly meetings.
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• Monitor the GMP systems currently in place to ensure compliance with documented policies.
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• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
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• Gather metric information for use in continuous improvement of areas of responsibility.
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Basic Qualifications:

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• Bachelor’s Degree OR
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• AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR
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• High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience
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Preferred Qualifications:

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• Strong knowledge of GMP, SOPs and quality control processes. ?
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• Identifying, writing, evaluating, and closing OOS’s and investigations.
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• Proficient in MS Word, Excel, Power Point and other applications.
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• Strong written and verbal communication skills.
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• Ability to communicate and work independently with scientific/technical personnel.
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• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
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• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
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• Preferred: Experience in the biotech and/or pharmaceutical industry.
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