Laboratory Services Quality Technician 3

CooperSurgical; Tucson (AZ); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

CooperSurgical in Tucson, AZ seeks a Quality Control Associate III to support quality systems including nonconformances, deviations, supplier evaluations, document review, calibration, and maintenance software tools.

The role collaborates with cross-functional teams to perform root cause analysis, risk remediation, and timely handling of environmental monitoring alarms with a strong quality mindset.

Qualifications

• Bachelor’s degree or equivalent experience in a relevant field.
• 3–5 years of related experience in quality systems or manufacturing.
• Strong written and verbal communication skills.

Responsabilités

• Adhere to CBR Corporate and Quality Control policies.
• Follow the laboratory's established policies and procedures for performance.
• Ensure all work performed adheres to cGLP/cGMP and GDP.
• Provide QC oversight and support as needed by QC customers.
• Support and participate in Quality Management System processes: Document Control, Deviations, Nonconformances, Supply Management, Validations/Verifications/Studies.

Connaissances

Root cause analysis

Cross-functional collaboration

Documentation practices

Formation

Bachelor’s degree or equivalent experience

Outils

Excel

Word

Outlook

Description du poste

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.

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.

Responsibilities

• Adhere to CBR 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 patriciate 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

Qualifications

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 organization.
• Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
• Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
• Computer Skills: Requires complete and broad knowledge of operating systems, techniques and practices typically learned through extensive experience and/or education. Must be proficient in Microsoft applications: Excel, Word, Outlook.
• Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle or feel, and talk or hear. The employee is frequently required to walk; sit and reach with hands and arms. The employee is occasionally required to stoop and kneel. The employee must frequently lift and/or move up to 50 pounds. On occasion, employee must frequently lift and/or move up to 100 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.
• Teamwork: Leads by example to maintain positive attitude and collegial work environment. Provides and is receptive to constructive feedback. Assist other team members as needed to accomplish the days or department tasks.

Work Environment

• Schedule/Work Hour Requirement:
  • This is an onsite position in Tucson, AZ.
  • Work hours dictated by the requirements of the business. As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime. Able to work mid-shifts, weekends, and holidays.
• Exposure Risk:
  • A requirement of this role is working in close proximity to blood products and tissue. Safeguards are implemented for employees to protect them from exposure to blood products and tissue.

Qualifications

Education/ Experience

• Bachelor’s degree (BA) from four-year college or university or Associates degree (A.A.) with three to five years related experience and/or training OR four to six years related experience and/or training; or equivalent combination of education and experience.