Onsite Quality Control Chemist with GMP & Bioassays

AGW; Frederick (MD); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Sick Pay

Job summary

AGW is seeking a Quality Control Chemist for an onsite contract in Frederick, MD. The role begins with a 7-week orientation and manufacturing onboarding training, followed by deployment to the agreed shift.

The position requires testing of materials and products using cell-based bioassays, flow cytometry, ELISA, and qPCR, with GMP and SOP compliance throughout. The contractor will generate CoAs, monitor data trends, maintain instruments, and participate in investigations and root-cause analysis

Qualifications

• Bachelor’s Degree OR AA Degree with 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.
• Strong knowledge of GMP, SOPs and quality control processes.
• Proficient in MS Word, Excel, Power Point and other applications.
• Strong written and verbal communication skills.

Responsibilities

• 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.

Skills

Verbal communication

Written communication

Education

Bachelor’s Degree

AA Degree with 2+ years Biotechnology QC

High School Diploma with 3+ years Biotechnology QC

Tools

MS Word

Excel

PowerPoint

Job description

AGW is seeking a Quality Control Chemist for an onsite contract in Frederick, MD. The role begins with a 7-week orientation and manufacturing onboarding training, followed by deployment to the agreed shift.

The position requires testing of materials and products using cell-based bioassays, flow cytometry, ELISA, and qPCR, with GMP and SOP compliance throughout. The contractor will generate CoAs, monitor data trends, maintain instruments, and participate in investigations and root-cause analysis