Quality Control Chemist
Job in
Frederick, Frederick County, Maryland, 21701, USA
Listed on 2026-08-15
Listing for:
The Planet Group
Full Time
position Listed on 2026-08-15
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Location:
Frederick, MD Onsite - Shift flexibility preferred
- :
Bachelor's Degree OR AA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience O - RHigh 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
- s:
Perform testing of raw materials, intermediates and final products by following analytical methods:
Cell based bioassays, Flow Cytometry, ELISA and qPCR assay - s.Work with internal and external resources to maintain lab in an optimal stat
- e.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 releas
- e.Maintains laboratory instruments for calibration and routine maintenan
- ce Author or revise SOPs, qualification/validation protocols and report
- s.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 meeting - s.Monitor the GMP systems currently in place to ensure compliance with documented policie
- s.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriat
- e.Gather metric information for use in continuous improvement of areas of responsibilit
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