Job Title - Quality Control Chemist
Location - Frederick, MD
Duration: 06 Months
Onsite - Shift flexibility preferred (First 7 weeks of training M-F)
· Time: 7am-530pm
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)
-
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.
