Quality Compliant Laboratory Specialist job in Covington
Covington CorTech LLC
| Job Ref: | 373803 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 33.00-33.00/Per Hour |
| Remote: | No |
Location |
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| City: | Covington |
| Post Code: | 30014 |
| Map: |
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Description |
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Join a team dedicated to ensuring the highest standards of product quality, patient safety, and regulatory compliance. As a Quality Complaint Laboratory Specialist, you will play a critical role in complaint investigations, laboratory testing, and quality assurance activities that directly support product quality and process excellence. Weekly pay, 401k, and health benefits Pay: 33.00 hourly Shift: M-F 8:45am-5:45pm Location: on-site What You'll Do In this role, you'll be at the forefront of quality investigations, working cross-functionally with manufacturing sites, suppliers, and quality teams to identify, analyze, and resolve product concerns. Key Responsibilities Conduct product testing and analysis within the Complaint Laboratory. Lead and support complaint investigations for company products and applicable externally manufactured products. Create, manage, and track investigation records within the complaint management system. Collaborate with manufacturing facilities to ensure timely completion of investigations. Set up, operate, troubleshoot, and maintain laboratory equipment and testing instruments. Perform testing and experiments in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Analyze data, document findings, and assist in developing investigation conclusions. Prepare thorough investigation reports and maintain accurate laboratory records. Provide technical Quality Engineering support to resolve product and process quality issues. Ensure timely communication of new findings to Failure Analysis specialists to support regulatory reporting requirements. Maintain compliance with departmental procedures, FDA regulations, ISO standards, and internal quality systems. Present technical findings and recommendations to peers, engineering teams, and management when needed. Support project teams and quality initiatives across the organization. Represent the organization and Quality Department in a professional manner. What Makes You Successful You are a detail-oriented problem solver who enjoys working in a laboratory environment and thrives on uncovering root causes. You combine strong technical skills with excellent communication and organizational abilities to manage multiple priorities while maintaining the highest quality standards. Qualifications Required Associate degree in a scientific discipline. 2?3 years of experience in a regulated industry, including co-op or internship experience. Prior laboratory experience and familiarity with laboratory testing methods. Working knowledge of laboratory instrumentation and equipment. Proficiency in Microsoft Excel, including Pivot Tables, VLOOKUPs, and data analysis functions. Strong written, verbal, and presentation communication skills. Ability to manage multiple assignments and meet deadlines with minimal supervision. Understanding of engineering fundamentals and manufacturing processes. Preferred Experience within the medical device, pharmaceutical, biotechnology, or other regulated industries. Knowledge of Quality System Regulations (QSR), GMP, GLP, ISO standards, AAMI standards, OSHA requirements, and FDA guidelines. American Society for Quality (ASQ) certification such as CQE, CQA, CQM, or equivalent. Impact of the Role This position contributes directly to product quality, regulatory compliance, and patient safety. Decisions made in this role can have significant operational, regulatory, financial, and healthcare implications. Success requires sound judgment, technical expertise, and a commitment to continuous improvement and quality excellence. Work Environment & Physical Requirements Primarily office and laboratory-based work environment. Regularly required to sit, walk, communicate, and move throughout laboratory areas. Must be comfortable working in a biohazard environment while following all safety protocols. Requires close vision and color vision for laboratory testing activities. May occasionally lift and move objects weighing up to 25 pounds. BD04123JD | |
ref: (373803)
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