QA Specialist II
Posted on :
08-10-2022
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1 Vacancy
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Job Description
Req ID : 1817577
Job Title: QA Specialist II
Location (On-site, Remote, or Hybrid?): Abbott Park, IL, ( on-site)
Contract Duration: Contract until 10/31/2023
Work Hours:700AM. - 330PM.
Location (On-site, Remote, or Hybrid?): Abbott Park, IL, ( on-site)
Contract Duration: Contract until 10/31/2023
Work Hours:700AM. - 330PM.
Summary
- 100% OnsiteSenior 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
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
1. 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.
2. Communications
- Communicate and collaborate effectively within the team and management.
3. Documentation
- Maintain relevant documents and records
4. Basic Requirements
- Performs quality testing in a high-paced laboratory environment.Has multiple certifications and is cross trained in other types of assays.
5. Manage Product and Process Improvements
- Participate in project and process improvement activities.
- Monitor performance of testing processes and implement required improvement activities.
- Suggests to manager and implements process improvements within own work area that fosters a culture of continuous improvement.
- Supports work area processes and product development/improvement projects.
- Provide quality support to key processes and product development/improvement projects.
- Takes a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently.
6. Management of Computer Systems
- Maintain and update relevant computer applications. Become an SME on the computer systems.
7. 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 client Global and Technical standards.
- Comply with client Quality System (QS) requirements.
8. Share Quality Knowledge
- Shares quality knowledge; liaising with colleagues within team.
9. Training
- Undertake all trainings and reviews as required on the Electronic Training Management System - ETMS.
10. Testing
- Platform lab (PRISM) and/or Biochemistry/Chemistrya.
- Complete quality testing as appropriate per product procedures and review all data to determine conformance with specifications.b.
- 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.c.
- Redline documents and provide adequate feedback.
11. Sample & File Storage
- Ensure storage of samples and documents in the appropriate filling systems.
12. Lab Safety
- Participates in lab safety
Minimum Education
Ideally a bachelor's or master's degree (or equivalent) in a science or closely related discipline and 2-3 years experience.
Employment Type
Full Time
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