Job Description
Job Title - Quality Control Chemist
Location - Frederick, MD
Onsite - Shift flexibility preferred
" Wed-Saturday
" Time: Day 3PM - 1:30AM EST
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.
