Laboratory Services Quality Technician 3

About the Role

The Quality Control Associate III is a mid-level quality-focused professional responsible for quality system processes, including Nonconformance, Deviations, Supply Evaluations, Document Review, Calibration, and Preventative Maintenance within Software Systems and Enterprise Resource Planning Software Systems. This role involves working with cross-functional teams to aid in root cause analysis, risk remediation, and management. The candidate will address, evaluate, and resolve alarms from the environmental monitoring system with a quality mindset.

The ideal candidate should possess strong written and verbal communication skills to foster cross-functional collaboration, lead by positive influence, maintain high integrity, and demonstrate a strong continuous improvement mindset.

Responsibilities

• Adhere to CBR Corporate and Quality Control policies.
• Follow laboratory-established policies and procedures when test systems are not within acceptable performance levels.
• Ensure all work strictly adheres to cGLP/cGMP and Good Documentation Practices (GDP).
• Provide QC oversight and support as needed by QC customers.
• Support and participate in Quality Management System Processes, including:
  • Document Control Program: revise and review company Standard Operating Procedures via electronic Document Quality Management System.
  • Deviations: create and investigate events using advanced troubleshooting and critical thinking skills; work cross-functionally to close deviations.
  • Nonconformances: create events and work cross-functionally to close non-conformances.
  • Supply Management: initiate supply evaluations to onboard new materials across the organization.
  • Validations, Verifications, and Studies: collaborate and review validations, verifications, and studies while maintaining accurate document records.
• Perform data entry, data analysis, tracking, trending, and create graphs and reports.
• Work cooperatively in a team environment to maintain cross-functional and cross-site consistency for quality systems records.
• Review electronic and hard copy quality records for accuracy and completion; resolve errors in a timely manner.
• Participate in training, projects, housekeeping, and other related activities.
• Train on a broad range of laboratory support functions and procedures, demonstrating expertise in technical skills within assigned discipline area(s).
• Routinely multi-task, problem-solve, and troubleshoot.
• Make informed and timely decisions independently.
• Maintain donor, client, and employee confidentiality.
• Respond to environmental monitoring alarms and support the environmental monitoring (EM) program.
• Support biorepository, facilities, and safety activities.
• Prioritize and organize work to meet established schedules and deadlines.
• Communicate effectively to foster cooperation and create a safe work environment.
• Provide audit preparation support activities.

Requirements

• Bachelor’s degree (BA) from a four-year college or university, or an Associate’s degree (A.A.) with three to five years of related experience and/or training; OR four to six years of related experience and/or training; or an equivalent combination of education and experience.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of employees.
• Proficiency in mathematical skills, including addition, subtraction, multiplication, division, computation of rates, ratios, percentages, and interpretation of bar graphs.
• Ability to apply common sense understanding to carry out instructions in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.
• Complete and broad knowledge of operating systems, techniques, and practices, typically gained through extensive experience and/or education.
• Proficiency in Microsoft applications: Excel, Word, Outlook.

Skills

• Strong written and verbal communication skills.
• Leadership by positive influence.
• High level of integrity.
• Strong continuous improvement mindset.
• Ability to multi-task and prioritize work effectively.
• Problem-solving and troubleshooting competencies.
• Teamwork: leads by example, maintains a positive attitude, provides and is receptive to constructive feedback, and assists team members as needed.

Physical Demands

• Regularly required to stand; use hands to finger, handle, or feel; and talk or hear.
• Frequently required to walk, sit, and reach with hands and arms.
• Occasionally required to stoop and kneel.
• Frequently lift and/or move up to 50 pounds.
• On occasion, must lift and/or move up to 100 pounds with assistance.
• Specific vision abilities required include close vision, distance vision, and ability to adjust focus.

Work Environment

This is an onsite position in Tucson, AZ. Work hours are dictated by business requirements, which may include extended hours, mandatory overtime, mid-shifts, weekends, and holidays to complete daily department goals or tasks.

A requirement of this role is working in close proximity to blood products and tissue. Safeguards are implemented to protect employees from exposure.