Quality Control Chemist - I*

Location: Frederick, MD | Onsite – shift flexibility preferred

Schedule

• Assigned shift: Wednesday–Saturday, 3:00 PM – 1:30 AM EST
• Training: first 7 weeks on Monday–Friday, 7:30 AM – 4:00 PM

About the role

We are seeking a Quality Control Chemist to support laboratory testing and quality operations within a regulated manufacturing environment. This role will perform analytical testing of materials and products, support laboratory investigations, maintain compliance with quality systems, and contribute to continuous improvement initiatives.

The ideal candidate will possess strong laboratory skills, a solid understanding of quality control principles, and experience working within a GMP-regulated environment.

Responsibilities

• Perform testing of raw materials, intermediates, and finished products using established analytical methods.
• Execute laboratory assays and testing procedures in accordance with approved protocols and standard operating procedures.
• Conduct testing using a variety of analytical techniques, including cell-based assays, flow cytometry, ELISA, PCR-based methods, and other applicable laboratory methodologies.
• Analyze and interpret test results to ensure compliance with quality standards and specifications.
• Maintain accurate, complete, and compliant laboratory records and documentation.
• Review test data, laboratory records, and supporting documentation to ensure accuracy and completeness.
• Support product release activities through documentation review and preparation of quality-related records.
• Monitor laboratory activities to ensure adherence to GMP requirements, procedures, and quality systems.
• Assist with investigations involving out-of-specification (OOS) results, deviations, and laboratory discrepancies.
• Participate in root cause analyses and corrective action activities.
• Support internal and external audit readiness efforts.
• Perform routine maintenance, calibration coordination, and performance monitoring of laboratory equipment and instrumentation.
• Collaborate with internal stakeholders and laboratory personnel to maintain an efficient and compliant laboratory environment.
• Assist in monitoring laboratory metrics and trends to support operational excellence and continuous improvement efforts.
• Provide updates regarding laboratory activities, priorities, and project status during team meetings.
• Author, revise, and maintain laboratory procedures, protocols, reports, and related documentation.
• Support qualification and validation activities as needed.
• Contribute to process improvements that enhance quality, compliance, efficiency, and data integrity.
• Participate in special projects and additional responsibilities as assigned.

Requirements

One of the following is required:

• Bachelor’s degree in a scientific discipline; OR
• Associate degree with 2+ years of relevant laboratory, quality control, or regulated industry experience; OR
• High School diploma with 3+ years of relevant laboratory, quality control, or regulated industry experience.

Preferred Qualifications

• Experience working in a GMP-regulated environment.
• Experience supporting quality control laboratory operations.
• Experience performing investigations related to OOS results, deviations, or quality events.
• Experience with laboratory data review and documentation practices.
• Experience supporting product testing within a regulated manufacturing environment.
• Bachelor’s degree in Chemistry, Biology, Biochemistry, Microbiology, or another scientific discipline (equivalent combinations of education and relevant experience will be considered).

Skills

• Strong understanding of quality control principles and laboratory operations.
• Knowledge of GMP requirements, documentation practices, and quality systems.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent attention to detail and commitment to data integrity.
• Strong written and verbal communication abilities.
• Ability to work independently and collaboratively within a team environment.
• Effective organizational and time-management skills.
• Ability to manage multiple priorities in a fast-paced laboratory setting.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Benefits

Full-time employees are eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.