QA Specialist III-29032

OLSA Resources, Inc.; Des Plaines (IL); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading staffing firm is seeking a Quality Technician in Des Plaines, Illinois. This entry-level position involves implementing quality systems and ensuring regulatory compliance in IVDs and Biologics. The ideal candidate should have analytical problem-solving skills, attention to detail, and effective communication abilities. Familiarity with cGMP and GLP standards is preferred. Candidates with medical device experience will be prioritized.

Qualifications

• Knowledge of regulations and standards affecting IVDs and Biologics.
• Ability to follow written controlled procedures.
• Familiarity with cGMP and GLP.

Responsibilities

• Implement and maintain the effectiveness of the quality system.
• Carry out tasks under direction of management.
• Generate exception/CAPA documentation for non-conformances.

Skills

Analytical problem solving

Attention to detail

Verbal communication skills

Written communication skills

Job description

Quality Technician Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes. Ensure compliance with world wide regulatory expectations/requirements. Major Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for carrying out tasks under direction of management and usually a contributor on broader goals. Develop compliant solutions to routine problems of limited scope. Responsible for demonstration of core competencies. Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Develops knowledge in such areas as incoming, in-process and final release testing, inspecting and/or processing and verifying work orders. Disposition incoming material for use in manufacturing and/or manufactured material for product for sale. Generates exception/CAPA documentation such as non-conformance reports reports required at the site for routine nonconformances.

Knowledge of regulations and standards affecting IVDs and Biologics. Basic understanding of how their function supports the business. Basic understanding of technical/business competencies.

Required experience includes: analytical problem solving techniques, ability to follow written controlled procedures, attention to details, basic computer/data management, good verbal and written communication skills. Highly desirable experience includes: knowledge of cGMP, GLP, CAPA and material/product traceability and control, manufacturing plant, operations, analytical chemistry, molecualr biology, statistical methods, research projects, team participation, laboratory testing and compliance, quality assurance experience, and understanding of basic clinical utility of products

Qualifications

Prefer candidates with medical device experience

Additional Information

This an entry level position.

Job Location