New 
Quality Control Chemist - I
 Spectraforce Technologies | |
 United States, Maryland, Frederick | |
 Oct 13, 2025 | |
|
Job Title: Quality Control Chemist - I
Duration: 04 months Location: Frederick, MD 21704 Onsite - Shift flexibility preferred * Wed-Saturday * Time: Day or Swing shift pending Description: 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 Responsibilities (include but are not limited to): * 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, Power Point 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. | |