Quality Control Chemist

Duration: 5 months

Location: Frederick, MD

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):

\n
• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
\n
• Work with internal and external resources to maintain lab in an optimal state.
\n
• 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.
\n
• Maintains laboratory instruments for calibration and routine maintenance
\n
• Author or revise SOPs, qualification/validation protocols and reports.
\n
• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
\n
• Provide updates at daily and weekly meetings.
\n
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
\n
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
\n
• Gather metric information for use in continuous improvement of areas of responsibility.
\n

Basic Qualifications:

\n
• Bachelor’s Degree OR
\n
• AA Degree and 2+ years’ experience in biotechnology or related field and Quality Control experience OR
\n
• High School Degree and 3+ years’ experience in biotechnology or related field and Quality Control experience
\n

Preferred Qualifications:

\n
• Strong knowledge of GMP, SOPs and quality control processes. ?
\n
• Identifying, writing, evaluating, and closing OOS’s and investigations.
\n
• Proficient in MS Word, Excel, Power Point and other applications.
\n
• Strong written and verbal communication skills.
\n
• Ability to communicate and work independently with scientific/technical personnel.
\n
• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
\n
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
\n
• Preferred: Experience in the biotech and/or pharmaceutical industry.
\n