The Senior Quality Technician is responsible for conducting bioanalytical and platform quality testing using the WWLIMS or QIMS systems and SAP, ensuring compliance with quality systems and protocols. This role will contribute to CAPA (Corrective and Preventive Actions) investigations, own and approve testing events, and maintain product and testing inventory. As a key point of contact for lab-related issues, the Senior Quality Technician will manage daily activities with minimal supervision, provide subject matter expertise (SME) on certifications, and may lead lab activities or projects.
Core Responsibilities:
- Quality System Maintenance: Implement and uphold the effectiveness of the quality system in compliance with GMPs (Good Manufacturing Practices) and GLPs (Good Laboratory Practices).
- CAPA: Investigate out-of-tolerance and out-of-specification (OOS) results, manage quality records, and take ownership of OOS and invalid results. May draft protocols for investigations.
- Communication: Collaborate effectively within the team and management to ensure smooth operations and resolution of issues.
- Documentation: Maintain all relevant records and documents in accordance with regulatory and procedural standards.
- Product and Process Improvements: Actively participate in product and process improvement initiatives, monitor testing processes, and suggest or implement improvements.
- Lab Operations: Ensure that lab activities are aligned with best practices, including ensuring GMPs and GLPs are followed. Assist with scheduling and manage lab safety initiatives.
- Computer Systems: Maintain and update laboratory computer applications, becoming an SME on these systems.
- Testing: Perform quality testing on platform labs (e.g., Alinity s and/or ARCHITECT) or biochemistry/chemistry assays, ensuring conformance with product specifications. Analyze and trend data, providing redlined documents and necessary feedback.
- Sample and File Storage: Ensure proper storage of samples and documentation in appropriate systems.
- Lab Safety: Participate in maintaining lab safety standards, ensuring compliance with EHS (Environmental, Health, and Safety) regulations.
Position Accountability/Scope:
- Execute daily testing activities in a fast-paced laboratory environment and escalate non-conformance issues when necessary.
- Collaborate closely with product technical support and take ownership of specific lab certifications, becoming an SME in designated areas.
- Provide quality support, document redlines, and manage projects as required. This role may involve leading lab projects or representing the lab in meetings.
- Advanced computer skills (Word, Excel) are essential.
Minimum Qualifications:
- Bachelor’s or Master’s degree (or equivalent) in a scientific field or a closely related discipline.
- 2-3 years of experience in a similar role, preferably in a quality or laboratory environment.
- Familiarity with quality systems, CAPA processes, and lab testing protocols.
- Strong communication, analytical, and problem-solving skills, with the ability to work independently and escalate issues appropriately.
- Advanced proficiency in computer applications (Word, Excel).
Preferred Qualifications:
- Prior experience in a regulated environment (e.g., pharmaceutical, biotechnology).
- Strong knowledge of GMP/GLP standards and lab safety practices.