Quality Site Administrator

Creative Testing Solutions•Memphis, TN

4d•Onsite

About The Position

The Quality Site Administrator manages the Analytics and Result Review Quality Assurance teams for a specific laboratory location. Under limited direction, 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 while following quality standards and regulatory guidelines. The role oversees day-to-day quality production activities, staffing and staff development, workflow, quality data and indicators, investigations, corrective actions, audits and inspections, process design, and CAPA activity. It also supports clinical trial studies, manages recalls and market withdrawals, and ensures analytic and result review processes meet regulatory standards and business needs. The position works in a laboratory and production environment with potential exposure to biological fluids, infectious organisms, extreme cold, production chemicals, moving machinery, and high noise. Personal protective equipment is required. Travel is less than 15%.

Requirements

Bachelor’s degree in science or a quality-related field.
At least five years of related quality assurance experience in a biological or pharmaceutical environment.
Previous supervisory or management experience.
Previous project or technical leadership experience.
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, with a focus on building and developing high-performing teams.
Ability to be organized and efficient and maintain a proactive attitude.
Excellent communication and influencing skills, with the ability to collaborate across all levels of the organization.
Proven record of implementing quality initiatives and driving continuous improvement.
Ability to apply practical solutions and adapt programs and services to specific requirements.
Ability to organize, prioritize, and execute variable workloads and multiple priorities.
Ability to work flexible hours to support a 24/7 work environment.
Ability to contribute creatively and effectively to development and company objectives.
Proficient computer skills.
Ability to apply abstract principles to solve complex conceptual issues.
Ability to meet the stated physical and environmental requirements, including handling items up to 35 pounds and using required personal protective equipment.

Nice To Haves

CMQOE, CQA, RAC, or Six Sigma certification.

Responsibilities

Manage the Quality Assurance team for a specific laboratory location.
Manage day-to-day quality production activities to ensure consistency and compliance across 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 assigned staff; build an inclusive culture of empowerment and accountability and foster personnel growth.
Plan and analyze workflow, delegate and prioritize activities, and ensure assignments and projects are completed on time and within budget.
Ensure system output meets laboratory quality standards and applicable regulatory guidelines.
Manage and escalate quality and compliance issues to stakeholders based on risk to CTS and clients; resolve complex problems.
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 and manage or perform evaluations of observations and errors.
Coordinate investigations, root cause analysis, corrective action development, audit-observation follow-up, response tracking, implementation monitoring, and effectiveness checks.
Lead and participate in process design for new and changed processes in identified operations.
Participate in review teams assessing nonconforming products, materials, or test results and customer impact, and ensure required actions are implemented.
Advocate and lead annual and quarterly objectives set by laboratory leadership.
Assist in oversight of Clinical Trial Studies.
Champion the OE culture and encourage team member involvement.
Implement and maintain leading and lagging indicators that 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, including implementation and efficacy monitoring.
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, including preparing written responses as applicable.
Manage and facilitate recalls and market withdrawals.
Review documents as defined by CTS systems, when applicable, to ensure process control and adherence to cGMP requirements.
Assure quality customer service and perform assigned duties in compliance with internal SOPs and external regulations.
Bring compliance issues to management's attention and perform other duties as assigned.