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Quality Assurance (QA) Specialist I

Artech LLCNorth Chicago, IL

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Title : Quality Assurance (QA) Specialist I

Location : North Chicago IL

Duration : 06+ Months

Pay Range : 25 / hr - $26 / hr

Individual will work in client's Operations Quality Assurance organization investigating return samples for medical device and combination product complaints and inquiries.
Responsible for product complaint documentation, investigations, identification of product defects and / or damage, and summarizing investigational data into a complaint handling system.
Interface with internal client's customers regarding product complaints. Responsibilities may include interaction with various third parties.

Responsibilities

Work in a laboratory setting wearing Personal Protective Equipment (e.g., gloves, lab coat, safety glasses).

Product complaint documentation, investigation, and review of all non-medical complaint content.

Responsible for reviewing complaints that involve a non-medical quality related problem.

Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GLP. Responsible that complaint data meets all regulatory requirements.

Comfortable working with sharps (e.g., needles) that are potentially biohazardous.

Identification of potential reportable events and notification to appropriate functional groups and management.

Reviews documents and recommends changes to help ensure team objectives are met.

Budgets their time with minimal supervision to effectively carry out assigned tasks and proposes improvements to processes. Takes initiative to be a key player in team activities.

Completes special projects in resourceful and effective ways to support overall group needs and requirements.

Qualifications

Solid written / verbal communication and organizational skills.

Knowledge and application of computer systems for word processing

Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

A bachelor’s degree in technology or scientific background preferred or 1-2 years of relevant work experience.

Notes :

1. What are the top 3-5 skills requirements this person should have?

Able to use time efficiently and effectively to complete workload

Good Organizational skills

Effective written and verbal communication skills

Works and collaborates well on a team

2. What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

Lab experience, bio-hazardous lab

Experience with pharmaceutical or medical devices

Pharmaceutical experience

Complaint investigation experience

3. What type of environment is this person working in?

Biohazardous lab, PPE (Safety glasses, Labcoat, gloves) required

Comfortable working with Sharps (needles) may contain biohazardous material

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Quality Assurance Specialist • North Chicago, IL

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