Job Description: Quality Control Chemist I
Location: 9021 Bennett Creek Blvd, Frederick, MD 21704
Pay Rate: $29/hr Bill Rate
Shift: Wednesday–Saturday, 3:00 PM – 1:30 AM EST
Training Schedule
For the first 7 weeks, contractors must work Monday–Friday, 7:30 AM – 4:00 PM for new hire orientation and manufacturing onboarding technical training. After completing training, the contractor will move to the agreed-upon shift.
Job Summary
The Quality Control Chemist I will perform laboratory testing of raw materials, intermediates, and finished products in a regulated biopharmaceutical environment. The position supports product release, laboratory operations, quality documentation, equipment maintenance, and GMP compliance.
Key Responsibilities
- Perform testing of raw materials, intermediates, and final products.
- Conduct analytical testing using cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
- Maintain laboratory equipment and perform routine calibration and maintenance.
- Monitor and trend laboratory data and review test records.
- Support in-process, drug substance, and drug product release testing.
- Provide information to support the generation of Certificates of Analysis (CoAs).
- Author and revise SOPs, qualification protocols, validation protocols, and reports.
- Assist with Out-of-Specification (OOS) investigations and root-cause analysis for deviations.
- Participate in daily and weekly meetings and provide status updates.
- Ensure compliance with GMP systems and documented procedures.
- Support continuous improvement initiatives and other assigned duties.
Basic Qualifications
Candidates must meet one of the following:
- Bachelor's degree; OR
- Associate's degree with 2+ years of biotechnology or related-field experience and Quality Control experience; OR
- High school diploma with 3+ years of biotechnology or related-field experience and Quality Control experience.
Preferred Qualifications
- Strong knowledge of GMP, SOPs, and Quality Control processes.
- Experience identifying, writing, evaluating, and closing OOS investigations.
- Proficiency in Microsoft Word, Excel, PowerPoint, and other applications.
- Strong written and verbal communication skills.
- Ability to work independently and communicate with scientific and technical personnel.
- Experience with analytical techniques such as:
- Flow Cytometry
- ELISA
- PCR / qPCR
- Cell-Based Bioassays
- Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11, 210, and 211.
- Previous pharmaceutical or biotechnology industry experience.
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