Quality Control Chemist

Job Description LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world. Job Title - Quality Control Chemist Location - Frederick, MD-Onsite Duration: 12 months PR: $30/hr to $35/hr Description: BACK END SWING. Wed-Sat 1pm-1130pm. FRONT END SWING. Sun-Wed 1pm-1130pm. 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. 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 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. 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). To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/ Should you have any questions, feel free to call me on (415) 868-6741 or send an email on sharif.khan@leadstackinc.com Job Type: Contract Pay: $30.00 - $35.00 per hour Expected hours: 40 per week Schedule: 10 hour shift Work Location: In person