Product Compliance Specialist

Job title: Product Complaint Analyst

Job location: North Chicago, Illinois 60085

Description:

Candidates with Product Quality Complaint experience preferred and especially Device Complaint related experience.

Responsibilities:

•Assure complaint records meet global requirements.

•Product complaint documentation, investigation, and review of all non-medical complaint content. Responsible for reviewing Medical complaints that involve a non-medical quality related problem. Provide quality customer service through coordination of return samples for investigation and follow up activities such as replacement of product.

•Ensures that complaint documentation meets Good Documentation Practices as well as GMP and GCP. This requires good analytical skills, technical writing and good documentation. Responsible that complaint files meet all regulatory requirements.

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

•Interface with Third Party Manufacturers, health care professionals, general public, internal customers, AbbVie functional areas and regulatory agencies.

Qualifications:

•Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

•Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.

•Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

•Solid written/verbal communication and organizational skills.

•Knowledge and application of computer systems for word processing and complaint management.

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

•A Bachelor Degree required. Preferred degree in technology or scientific background (MLT, LPN, RN).

•0-3 years’ work experience in a cGMP related industry or in a clinical setting is preferred

The top 5 skills/requirements this person is required have?

Required Skill 1: Detail oriented

Required Skill 2: Microsoft Excel Knowledge and Experience – Pivot tables, sorting, filtering are a must

Required Skill 3: Adaptive to change

Required Skill 4: Self-starter/independent worker

Required Skill 5: Taking initiative to improve/create efficiency

? 1 year quality and/or complaint handling experience. Degree.

3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.

Job Type: Contract

Pay: $20.00 - $24.00 per hour

Experience level:

• 1 year

Schedule:

• 8 hour shift

Experience:

• FDA regulations: 1 year (Preferred)

Ability to Commute:

• Waukegan, IL 60085 (Required)

Ability to Relocate:

• Waukegan, IL 60085: Relocate before starting work (Required)

Work Location: In person

Salary : $20 - $24