Sr. Quality Technician

About the role

Senior Quality Technician responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. Provides inputs to facilitate CAPA investigations as required. Will be required to own and approve any testing events. Maintains product and testing inventory and complies with the quality system. Undertakes the role as Senior Quality Technician and executes daily activities with minimal supervision. Becomes a point of contact for lab issues and may be called on to aid with scheduling activities. Provides input on testing and is an SME (Subject Matter Expert) on their certifications. May provide testing redlines and input and may be called on to project manage and lead any lab activities.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• CAPA - Investigate standard testing out of tolerance and out of specification (OOS) results including complaints. Support ticket trending process and maintain quality records. Take ownership and approve any OOS, invalid, and/or aberrant results. May write protocols for investigations.
• Communicate and collaborate effectively within the team and management.
• Maintain relevant documents and records.
• Perform quality testing in a high-paced laboratory environment. Has multiple certifications and is cross-trained in other types of assays.
• Participate in project and process improvement activities. Monitor performance of testing processes and implement required improvement activities. Suggest and implement process improvements within own work area that fosters a culture of continuous improvement. Support work area processes and product development/improvement projects.
• Provide quality support to key processes and product development/improvement projects.
• Take a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently.
• Maintain and update relevant computer applications. Become an SME on the computer systems.
• Support manufacturing and testing operations as required, adhering to GMPs and GLPs. Possess a more involved understanding of the Quality System, including the subsystems, and be familiar with the Quality System Key processes.
• Keep abreast of the standards that regulate the industry.
• Participate and complete all trainings and reviews as required on the Electronic Training Management System (ETMS).
• Conduct business in a manner that will protect human health, safety, and the environment by complying with all applicable EHS laws, as well as Abbott Global and Technical standards. Comply with Abbott Quality System (QS) requirements.
• Share quality knowledge, liaising with colleagues within the team.
• Complete quality testing as appropriate per product procedures and review all data to determine conformance with specifications.
• Provide information for tracking and trending of data as required. Take appropriate action per procedural requirements and schedule when test results specifications are not met.
• Ensure storage of samples and documents in the appropriate filing systems.
• Participate in lab safety.

Requirements

• Bachelor’s degree in a science or closely related discipline.
• 2-3 years of related work experience with a good understanding of specified functional area.

Preferred Qualifications

• Detailed knowledge of FDA, GMP, and IVDR regulations.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $25.00 – $50.00 per hour. In specific locations, the pay range may vary from the range posted.