QA Specialist III — GMP CAPA & NCR Leader

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical benefits starting day 1

Paid volunteerism starting day 1

Paid time off (PTO) up to 17 days

Wellness time off (WTO)

Paid holidays (10)

Shift differential

Job summary

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, is seeking a senior Quality Assurance professional to perform QA review and technical oversight of GMP investigations across aseptic filling operations.

This role ensures deviations, CAPAs, action items, and root-cause analyses are scientifically sound, adequately documented, and compliant. Lead cross-functional meetings, drive timely closure of non-conformances, and mentor the Quality team while contributing to site metrics.

Qualifications

• Bachelor’s degree in Life Sciences or related field and/or 8+ years of related work experience.
• 3+ years of technical writing experience including owning quality investigations and CAPA/action items.
• Knowledge of quality principles in pharma/biopharma/biotech manufacturing.
• Thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
• Client-facing experience leading meetings to close NCRs on-time and meet customer service metrics.

Responsibilities

• Review deviation investigations, CAPAs, action items, and root cause analyses for scientific soundness and compliance.
• Lead cross-functional meetings to drive effective root cause analysis and timely completion of non-conformance investigations.
• Initiate site quality metrics and non-conformance trend reviews (daily/weekly/monthly).
• Perform QA review and approval of cGMP documentation to support continuous improvements.
• Support agency, customer, and vendor audits as needed.
• Provide training and mentorship to the Quality team on writing and reviewing non-conformance investigations.

Skills

Quality Assurance

Root Cause Analysis

CAPA Management

Non-conformance

Client-facing

GMP Compliance

Cross-functional collaboration

Meeting facilitation

Documentation judgment

Education

Bachelor’s degree in Life Sciences or related field

Tools

cGMP

FDA guidelines

Regulatory standards

Job description

Grand River Aseptic Manufacturing, Inc. in Grand Rapids, MI, is seeking a senior Quality Assurance professional to perform QA review and technical oversight of GMP investigations across aseptic filling operations.

This role ensures deviations, CAPAs, action items, and root-cause analyses are scientifically sound, adequately documented, and compliant. Lead cross-functional meetings, drive timely closure of non-conformances, and mentor the Quality team while contributing to site metrics.