Quality Associate II

Job Title: Quality Associate II
Location: Medina, NY 14103 (Hybrid)
Duration: 12 Months (Potential for Extension)
Shift: Standard Business Hours
 
Role Overview:
The Quality Associate II plays a key role in managing product complaints, including triaging, investigating, and responding to internal and external customer concerns. The role demands strong technical writing, regulatory knowledge, and the ability to operate independently within a cGMP environment.

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Key Responsibilities:

• Triage and assess incoming complaints to determine risk and next steps.
• Gather relevant data to support complaint investigations.
• Evaluate reportability of complaints per regulatory requirements.
• Draft technical customer response letters based on investigation outcomes.
• Engage in quality improvement initiatives such as CAPAs and product improvement projects.
• Lead or contribute to assigned projects; may act as technical approver.
• Manage daily workflow and escalate issues as needed.
• Support training and mentoring of team members.
• Perform duties consistent with previous quality levels.

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Qualifications & Skills:

• Bachelor’s degree required.
• 2–5 years of experience in a cGMP-regulated industry or clinical setting.
• Strong knowledge of FDA regulations: 21 CFR 803, 806, 820, 211.
• Proficient in technical writing and customer-facing documentation.
• Familiar with manufacturing processes and product usage.
• Excellent communication, organizational, and analytical skills.
• Ability to prioritize tasks and work independently with minimal supervision.
• Skilled in complaint management systems, Microsoft Office, and data analysis tools.