Quality Site Administrator

Job Overview

Under limited direction, this position is responsible for the overall management of the Analytics and Result Review Quality Assurance teams for a specific laboratory location. The Quality Site Administrator monitors and evaluates the quality system for compliance with applicable regulations, improvement initiatives, and business needs. This role closely partners with laboratory operations teams to ensure the laboratory meets current production requirements in a manner compliant with laboratory quality standards and current regulatory guidelines.

• Manages the QA team for a specific laboratory location.
• Manages day‑to‑day quality production activities to ensure consistency and compliance across quality review, test result reporting, and donor deferral activities.
• Ensures appropriate staffing, development, training, and problem resolution across shifts.
• Hires, supervises, trains, and evaluates staff performance.
• Fosters a strong culture of empowerment, accountability, and inclusion.
• Plans and analyzes workflow, delegates and prioritizes activities, and ensures timely completion of tasks within budget.
• Ensures system output meets current laboratory quality standards and regulatory guidelines.
• Escalates quality and compliance issues based on risk to stakeholders.
• Resolves complex problems and provides issue resolution.
• Manages laboratory tracking, trending data collection, analysis, and presentation for monthly Quality Management Review meetings.
• Facilitates proactive solutions based on quality data results.
• Leads the error management program.
• Supports operations by evaluating observations and errors; conducts investigations, root‑cause analysis, and corrective action development.
• Performs follow‑up on audit observations, tracks responses, and monitors implementation of corrective actions.
• Leads and participates in process design activities for new or changed processes.
• Participates in review teams to evaluate nonconforming products, materials, or test results.
• Advocates and leads annual and quarterly objectives as determined by laboratory leadership.
• Assists in oversight of Clinical Trial Studies.
• Champions an O.E. culture and encourages team involvement.
• Implements and maintains leading and lagging indicators for process and product quality.
• Partners with departmental leads to mitigate risks in processes and performance.
• Facilitates CAPA program and monitors its efficacy.
• Ensures analytic and result review processes meet regulatory standards and business needs.
• Acts as host and primary liaison for external and internal inspections/audits; provides written responses.
• Manages recalls and market withdrawals.
• Performs document reviews to ensure control of processes and adherence to cGMP requirements.
• Provides quality customer service to all customers.
• Performs all duties in compliance with internal SOPs and external regulations.
• Brings compliance issues to management and performs other assigned duties.

• Education:
  
  Bachelor’s degree in science or a related quality field.
• Experience:
  
  At least five years of quality assurance experience in a biological or pharmaceutical environment.
• Previous supervisory, management, or technical leadership experience.
• Proficiency with quality assurance programs, systems, and procedures including benchmarking, risk management, continuous improvement, and industry regulations.

• CMQOE, CQA, RAC, or Six Sigma certification.

• Excellent leadership and people‑management skills.
• Organized, efficient, proactive.
• Excellent communication and influencing skills across all levels.
• Track record of implementing quality initiatives and driving continuous improvement.
• Ability to adapt programs and services to meet specific requirements.
• Ability to manage a variable workload and multiple priorities.
• Willingness to work flexible hours to support a 24/7 environment.
• Proficient computer skills.
• Analytical thinking and problem‑solving ability.

Lab work environment: exposure to biological fluids, extreme cold (≤−20°C), chemicals, moving machinery, and high noise levels. Personal protective equipment is required. Vision requirements include close, distance, color, peripheral, and depth perception. Travel requirements: less than 15% of time. Shift work: 5+ hours per shift may involve sitting, standing, handling, finger dexterity, up to 3 hours per shift walking, climbing, bending, squatting, reaching.

Ability to lift and move items up to 35 pounds.

Shift1:
Monday to Friday, 8:00AM to 4:30PM.

All candidates who receive a conditional written offer of employment will be required to undergo a pre‑employment drug test in accordance with the company’s guidelines.

The company is an Equal Opportunity Employer. We are committed to compliance with federal, state, and local laws that prohibit discrimination.