Purpose:

Describe the primary goals, objectives or functions or outputs of this position.

• Individual will work in Post Market QA 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 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:

Are you open to look at candidates willing to relocate? No

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

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

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

What is the expected work schedule? Is overtime offered or required? If yes, how many hours? First shift, Overtime is offered

Does this position offer the ability to work remotely on a full or hybrid basis? No but there are some aspects that can be done from home.

Will there be Domestic and/or International Travel? No

Salary: $13.46 - $27.00 per hour

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Ability to commute/relocate:

• North Chicago, IL 60064: Reliably commute or planning to relocate before starting work (Required)

Experience:

• complaints investigation: 1 year (Preferred)
• quality assurance: 1 year (Preferred)
• pharma or medical device industry: 1 year (Preferred)
• Product complaint documentation, investigation: 1 year (Preferred)

Work Location: One location

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