Quality Control Chemist: Biotech Assay Expert

ACL Digital; Frederick (MD); On-site; USD 55,000 - 75,000; Full time

Job summary

ACL Digital is hiring for a Quality Control Analyst to perform testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. The analyst will maintain the lab, review data for CoAs, and support product release in a GMP environment.

The role requires an AA degree with 2+ years in biotech or a related field, or a high school diploma with 3+ years in biotech/QC.

Qualifications

• AA Degree with 2+ years’ biotech or QC experience OR High School Degree with 3+ years’ biotech/QC experience.
• Experience with GMP, SOPs and quality control processes.
• Proficient with MS Word, Excel, PowerPoint and related applications.
• Ability to communicate and work independently with scientific/technical personnel.

Responsibilities

• Test materials and products using cell-based bioassays, flow cytometry, ELISA and qPCR.
• Maintain lab with internal/external resources to keep it in optimal state.
• Review test data and prepare information for CoAs and product release.
• Calibrate and maintain laboratory instruments.
• Draft or revise SOPs, qualification/validation protocols and reports.
• Support investigations of OOS results and determine root causes.
• Provide updates at daily/weekly meetings and monitor GMP systems for compliance.
• Review proposed changes to systems and procedures for regulatory submissions.
• Gather metrics for continuous improvement.
• Perform additional duties as required.

Skills

GMP knowledge

Quality control

Investigations

Documentation

Statistical thinking

Communication

Education

AA degree in biotechnology or related field

High School Diploma with 3+ years of biotech/QC experience

Tools

MS Word

MS Excel

PowerPoint

Job description

ACL Digital is hiring for a Quality Control Analyst to perform testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR. The analyst will maintain the lab, review data for CoAs, and support product release in a GMP environment.

The role requires an AA degree with 2+ years in biotech or a related field, or a high school diploma with 3+ years in biotech/QC.