Quality Control Chemist - I

Responsibilities:

• Excellent employment opportunity for a Quality Control Chemist in the Frederick MD area. (Onsite)
• 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 inprocess 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.
  

Experience:

• Bachelors Degree OR
• AA Degree and 2 years of experience in Biotechnology or related field and Quality Control experience OR
• High School Degree and 3 years of experience in Biotechnology or related field and Quality Control experience
• Strong knowledge of GMP SOPs and quality control processes.
• Identifying writing evaluating and closing OOSs 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.