Laboratory Services Quality Technician

Job Description

The Quality Control Associate III is a mid-level quality focused professional responsible in quality system processes which include Nonconformance, Deviations, Supply Evaluations, Document Review, Calibration and Preventative Maintenance Software System and Enterprise Resource Planning Software System. In this role the candidate will work with cross functional teams aiding in root cause analysis, risk remediation and management. Additionally, the candidate will address, evaluate, and resolve alarms timely from the environmental monitoring system with a quality mindset.

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

Essential Functions & Accountabilities:

• Adhere to C  Corporate and Quality Control policies.
• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance.
• Ensure all work performed strictly adheres to cGLP/cGMP.
• Exercise Good Documentation Practices (GDP).
• Follow the laboratory's procedures for reporting and maintaining records.
• Provide QC oversight and support as needed by QC customers.
• Support and participate in Quality Management System Processes such as:
• Document Control Program: revise and review of company Standard Operating Procedure via electronic Document Quality Management System.
• Deviations:
  Create and investigate events while using advanced troubleshooting and critical thinking skills. Works cross functionally to expand discussions in support of closing deviations.
• Nonconformances:
  Create the event and works cross functionally to expand discussions in support of closing the non-conformance.
• Supply Management:
  Initiate supply evaluations to onboard new material across the organization.
• Validations, Verification and Studies:
  Collaborate and review validations, verifications and studies while maintaining accurate document records.
• Perform data entry, data analysis, tracking, trending, creating graphs and reports
• Work cooperatively in a team environment to maintain cross functional, and cross site processes and procedural consistency for quality systems records.
• Review electronic and hard copy quality records for accuracy and completion. Recognizes errors and resolves them in a timely manner.
• Participate in training, projects, housekeeping, and other related activities.
• Train on a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills and procedures within assigned discipline area(s).
• Capable of routinely multi-tasking.
• Problem solving and troubleshooting competencies.
• Make informed and timely decisions independently.
• Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Apply common sense understanding when working independently on departmental projects, timelines and dealing with compliance issues.
• Maintain donor, client, and employee confidentiality.
• Respond to environmental monitoring alarms.
• Support the environmental monitoring (EM) program.
• Support biorepository, facilities and safety activities.
• Prioritize and organize work to deliver assignments according to established schedules and deadlines.
• Communicate in a manner that fosters cooperation and creates a safe environment for those involved.
• Provide audit preparation support activities.

Travel:

• N/A

Knowledge, Skills and Abilities:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Language
  
  Skills:
  
  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 of…