QA Technician II
100 Abbott Park Road Downey, IL 60064 US
Job Description
*Depending on experience
Summary
QA Technician II responsible for bioanalytical quality testing within the QIMS and SAP system. Provides inputs to facilitate CAPA investigations as required. Owns and approves any testing events. Maintains product and testing inventory and complies with the quality system. Undertakes the role as Quality Technician II 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.Â
Core Job Responsibilities
1.   Responsible for implementing and maintaining the effectiveness of the Quality system.
2.   Basic Requirements – Performs quality testing in a high-paced laboratory environment and has multiple certifications.
3.   Experience with the following bioanalytical techniques: HPLC, SDS-PAGE, Western Blot, Dot Blot, Infrared Spectroscopy, UV-Vis Absorbance, ELISA, Mass Spectrometry (MS), microtiter plate methods.
4.   CAPA - Investigates standard testing out of tolerance and out of specification results including complaints. Supports ticket trending process and maintains quality records.
5.   Communications - Communicate and collaborate effectively within the team and management.
6.   Documentation - Maintain accurate and complete documents and records.
7.   Manage Product and Process Improvements - Participate in project and process improvement activities. Monitor performance of testing processes, implements process improvements, and 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.Â
8.   Management of Computer Systems - Maintain and update relevant computer applications.Â
9.   Quality/Compliance -Support manufacturing and testing operations as required, adhering to GMPs and GLPs. Possess a basic 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 ISOtrain Learning Management System. 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.
10.   Share Quality Knowledge - Shares quality knowledge, liaising with colleagues within team.
11.   Training - Undertake all trainings and reviews as required.
12.   Sample & File Storage - Ensure storage of samples and documents in the appropriate filling systems.
13.   Lab Safety – Participates in lab safety
Position Accountability/Scope:
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. Become an SME on lab certifications. Basic computer skills are needed.
Minimum Education
Ideally a bachelor’s or master's degree (or equivalent) in a science or closely related discipline and 2-3 years' experience.
Â
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Downey, IL
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.