Position Details:

Client: Pharmaceuticals

Job Title: QA Specialist II/Product Complaint Analyst I

Duration: 6 Months

Location:  North Chicago, IL  60085

Job Description:

The focus will be in the Product Complaints area Candidate will be performing assessment of efficacy reports. Seeking candidates with complaint intake or handling experience. The position will be detail oriented, and require review of attachments, labelling and detailed complaint report . Candidates must be able to make decisions independently. Additionally responsibilities may include project support, mailbox monitoring and cross-functional support within PMQA.

Key responsibilities:

• Receive, document, and assess product complaints, particularly efficacy-related reports.
• Review complaint details, attachments, and product labeling for completeness and accuracy.
• Make independent decisions on complaint classification, escalation, or closure.
• Ensure all records are maintained in compliance with regulatory and quality standards.
• Coordinate with cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, Medical Affairs) for complaint resolution and follow-up.
• Provide support across PMQA functions as needed.
• Participate in quality-related projects or initiatives.
• Support process improvements or system updates as required.
• Monitor shared complaint mailboxes and ensure timely response and triage.
• Communicate effectively with stakeholders regarding complaint handling status or required actions.
• Ensure adherence to internal procedures and regulatory guidelines (e.g., FDA, GMP).
• Contribute to audits and inspections as needed.

Qualifications:

• 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.
• 1 year quality and/or complaint handling experience. 
• Nice to have : 3-5 years quality and/or complaint handling experience. Degree in science, nursing, or equivalent.
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Skills:

• Detail oriented 
• Microsoft Excel Knowledge and Experience – sorting, filtering are a must
• Adaptive to change 
• Self-starter/independent worker 
• Taking initiative to improve/create efficiency