Quality Site Administrator

Creative Testing Solutions•Memphis, TN

About The Position

Under limited direction, the Quality Site Administrator manages the Analytics and Result Review Quality Assurance teams for a specific laboratory location. The role monitors and evaluates the quality system for compliance with applicable regulations, improvement initiatives, and business needs, and partners closely with laboratory operations to meet production requirements in compliance with laboratory quality standards and current regulatory guidelines. The position oversees quality production activities, staffing, training, workflow, quality data, error management, audit follow-up, CAPA, inspections, recalls, and process improvement. It also collaborates across departments, supports clinical trial studies, and ensures analytical and result review processes meet regulatory standards and business needs. The work is performed in a laboratory environment with exposure to biological fluids, potential infectious organisms, extreme cold, chemicals, machinery, and production-floor noise. Personal protective equipment is required. Travel is less than 15%.

Requirements

Bachelor’s degree in a science or quality-related field.
At least five years of related quality assurance experience in a biological or pharmaceutical environment, including previous supervisory or management experience and project or technical leadership.
Demonstrated proficiency with Quality Assurance programs, systems, and procedures, including quality benchmarking, risk management, continuous improvement programs, and industry-specific regulations.
Excellent leadership and people-management skills, focused on building and developing high-performing teams.
Ability to be organized and efficient, with a proactive attitude.
Excellent communication and influencing skills, with the ability to collaborate across all levels of the organization.
Proven ability to implement quality initiatives and drive continuous improvement.
Ability to apply practical approaches and adapt programs and services to specific requirements.
Ability to organize, prioritize, and execute a variable workload and multiple priorities.
Ability to work flexible hours to support a 24/7 work environment.
Ability to contribute to development and company objectives and achieve goals in creative and effective ways.
Proficient computer skills.
Ability to apply abstract principles to solve complex conceptual issues.
Ability to meet the stated laboratory physical demands, including prolonged sitting, standing, and handling; finger dexterity and pinching; and walking, climbing, bending, squatting, reaching, grasping, carrying, moving, and lifting items up to 35 pounds.
Ability to work in a laboratory environment involving biological fluids and potential infectious organisms, extreme cold (≤ -20°C), production chemicals, moving machinery, production equipment, and high noise levels; required to use personal protective equipment.

Nice To Haves

CMQOE, CQA, RAC, or Six Sigma certification.

Responsibilities

Manage the Quality Assurance team and day-to-day quality production activities at a specific laboratory location, maintaining consistency and compliance in quality review, test result reporting, and donor deferral activities.
Ensure appropriate staffing, development, training, and problem resolution across two or more shifts; hire, supervise, train, and evaluate staff, while fostering accountability, inclusion, and personnel growth.
Plan and analyze workflow, delegate and prioritize activities, and ensure work is completed on time and within budget in accordance with quality standards and regulatory guidelines.
Manage and escalate quality and compliance issues according to risk, resolve complex problems, and provide issue resolution.
Manage laboratory tracking and trending data collection, analysis, and presentation for monthly Quality Management Review meetings, and facilitate proactive solutions based on results.
Lead the error management program; evaluate observations and errors, coordinate investigations and root cause analysis, and develop corrective actions with involved departments.
Follow up on audit observations, track responses, monitor implementation, and verify corrective action effectiveness.
Lead and participate in process design for new and changed processes in identified operations.
Participate in review teams evaluating nonconforming products, materials, or test results; assess customer impact and ensure required actions are implemented.
Advocate and lead annual and quarterly objectives established by laboratory leadership.
Assist with oversight of Clinical Trial Studies.
Champion Operational Excellence culture and encourage team member involvement.
Implement and maintain leading and lagging indicators to monitor process and product quality and execution of standard procedures.
Partner with departmental leads to mitigate risks affecting laboratory quality and build cross-functional relationships.
Facilitate and coordinate the CAPA program, overseeing implementation and monitoring CAPA effectiveness.
Ensure analytic and result review processes meet regulatory standards and business needs.
Host and serve as primary liaison for external and internal inspections and audits, provide written responses as applicable, and ensure corrective actions are implemented and effective.
Manage and facilitate recalls and market withdrawals.
Review documents as defined by CTS systems to ensure process control and adherence to cGMP requirements, as needed.
Provide quality customer service to all customers.
Perform assigned duties in compliance with internal SOPs and external regulations and bring compliance issues to management's attention.
Perform other duties as assigned by management.