Sr. Quality Technician

Abbott Laboratories • Lewes, DE

1d • $25 - $50 • Onsite

About The Position

The Senior Quality Technician is responsible for bioanalytical and/or platform quality testing within the WWLIMS or QIMS system and SAP system. This role provides inputs to facilitate CAPA investigations as required and will be responsible for owning and approving any testing events. The technician will maintain product and testing inventory and comply with the quality system. This role executes daily activities with minimal supervision, acts as a point of contact for lab issues, and may assist with scheduling activities. The Senior Quality Technician provides input on testing and is a Subject Matter Expert (SME) on their certifications. They may also provide testing redlines and input, and may be called upon to project manage and lead lab activities.

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
• Advanced computer skills.

Nice To Haves

• Detailed knowledge of FDA, GMP and IVDR regulations
• Has multiple certifications and is cross trained in other types of assays.
• Become an SME on lab certifications.
• Become an SME on the computer systems.
• Possess a more involved understanding of the Quality System; including the subsystems and is familiar with the Quality System Key processes.
• Keep abreast of the standards that regulate our industry.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• 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.
• Communicate and collaborate effectively within the team and management.
• Maintain relevant documents and records.
• Perform quality testing in a high-paced laboratory environment.
• 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.
• Support manufacturing and testing operations as required, adhering to GMPs and GLPs.
• Participate and take 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 at the Abbott Global and Technical standards.
• Comply with Abbott Quality System (QS) requirements.
• Share quality knowledge, liaising with colleagues within 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 filling systems.
• Participate in lab safety.

Benefits

• Career development with an international company
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• The Freedom 2 Save student debt program
• FreeU education benefit
• A company recognized as a great place to work in dozens of countries around the world
• Named one of the most admired companies in the world by Fortune.
• Recognized as one of the best big companies to work for
• Recognized as a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior