Full Job Description
Core Job Responsibilities
- Responsible for implementing and maintaining the effectiveness of the quality system.
- CAPA - Investigates standard testing out of tolerance and out of specification (OOS) results including complaints. Supports ticket trending process and maintains quality records. Takes ownership and approves any OOS, invalid, and/or aberrant results. May write protocols for investigations.
- Communications - Communicate and collaborate effectively within the team and management.
- Documentation - Maintain relevant documents and records.
- Basic Requirements - Performs quality testing in a high-paced laboratory environment. Has multiple certifications and is cross trained in other types of assays.
- Management of Computer Systems - Maintain and update relevant computer applications. Become an SME on the computer systems.
- Quality/Compliance -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 is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry. 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 Global and Technical standards. Comply with Quality System (QS) requirements.
- Share Quality Knowledge - Shares quality knowledge; liaising with colleagues within team.
- Training - Undertake all trainings and reviews as required on the Electronic Training Management System - ETMS.
- 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.
- Redline documents and provide adequate feedback.
- Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.
- Lab Safety - Participates in lab safety
- Individuals execute daily testing in a high-paced laboratory environment.
- Identify and escalate any potential non-conformances / issues to quality professionals.
- Work closely with product technical support.
- Perform activities as assigned by quality professionals / manager.
- Apply appropriate actions to resolve with support from quality professionals.
- Support relevant activities. Help with any data pulls or document redlines/updates.
- Become an SME on lab certifications. Leader within the lab. May also lead lab projects and be called on to attend meetings.
- Advanced computer skills (Word, Excel) are a must.
- Ideally a bachelor's or master's degree (or equivalent) in a science or closely related discipline and 2-3 years' experience.
Job Information
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