Children's National Medical Center
CTL Quality Assurance Associate I
Children's National Medical Center, Washington, District of Columbia, us, 20022
Job Description - CTL Quality Assurance Associate I (2500010R)
Considering making an application for this job Check all the details in this job description, and then click on Apply. Position Overview The CTL Quality Assurance (QA) Associate I is a key member of the CTL QA team, responsible for quality assurance and improvement activities within the Cellular Therapy Laboratory. This role involves managing quality assurance activities to ensure systems are safe, effective, compliant with regulations, and aligned with standards such as FDA's GMP, GTP, or FACT. Qualifications Associate's Degree in Biology or a related discipline (Required); Bachelor's Degree preferred. 1 year experience in a cGMP environment or clinical laboratory (Preferred). Knowledge of cGMP, FDA policies related to biotech products, and sterile drug manufacturing. Responsibilities Contribute to quality systems including investigations, change control, CAPA, and risk management. Lead document control processes, including SOP drafting and updates. Support continuous improvement initiatives and participate in audits and investigations. Assist during regulatory inspections and client audits. Manage facility maintenance to ensure readiness for inspections. Coordinate with QC specialists and Lab Managers on equipment qualification, calibration, and preventive maintenance. Track quality incidents and assist in investigations. Adhere to cGMP guidelines and departmental policies. Additional Duties Collaborate effectively with team members and management. Promote safety and compliance in the workplace. Participate in performance improvement and problem-solving activities. Location and Schedule Primary Location: Washington, DC at CN Hospital (Main Campus) Work Schedule: 9:00 AM - 5:30 PM, Full-Time, Day Shift Compensation Salary Range: $42,702.40 - $71,156.80 annually Children's National Hospital is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace policy.
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Considering making an application for this job Check all the details in this job description, and then click on Apply. Position Overview The CTL Quality Assurance (QA) Associate I is a key member of the CTL QA team, responsible for quality assurance and improvement activities within the Cellular Therapy Laboratory. This role involves managing quality assurance activities to ensure systems are safe, effective, compliant with regulations, and aligned with standards such as FDA's GMP, GTP, or FACT. Qualifications Associate's Degree in Biology or a related discipline (Required); Bachelor's Degree preferred. 1 year experience in a cGMP environment or clinical laboratory (Preferred). Knowledge of cGMP, FDA policies related to biotech products, and sterile drug manufacturing. Responsibilities Contribute to quality systems including investigations, change control, CAPA, and risk management. Lead document control processes, including SOP drafting and updates. Support continuous improvement initiatives and participate in audits and investigations. Assist during regulatory inspections and client audits. Manage facility maintenance to ensure readiness for inspections. Coordinate with QC specialists and Lab Managers on equipment qualification, calibration, and preventive maintenance. Track quality incidents and assist in investigations. Adhere to cGMP guidelines and departmental policies. Additional Duties Collaborate effectively with team members and management. Promote safety and compliance in the workplace. Participate in performance improvement and problem-solving activities. Location and Schedule Primary Location: Washington, DC at CN Hospital (Main Campus) Work Schedule: 9:00 AM - 5:30 PM, Full-Time, Day Shift Compensation Salary Range: $42,702.40 - $71,156.80 annually Children's National Hospital is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace policy.
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