QC Biochemist

Job Description

Job Description

Currently we have an opening for a QC Biochemist located in Frederick, MD.  Details for the position are as follows:

• 6-month contract with the possibility of extending or converting to permanent based on performance and budget.
• For the first 7 weeks of the assignment , all contractors are required to work Mon-Fri 7:30am-4pm to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks , the contractor is deployed onto their agreed upon shift.
• Shift: Wed-Saturday - 3PM - 1:30AM EST
• 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.

• 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

• 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.