QA Specialist II - GMP, Investigations & Compliance

Kindeva; Missouri; On-site; USD 70,000 - 100,000; Full time

Job summary

Kindeva Drug Delivery is seeking a QA Specialist I/II to provide advanced quality oversight, evaluate batch documentation, and manage product disposition in a fast-paced manufacturing setting.

You will partner with cross-functional teams to ensure regulatory compliance, lead investigations, and support continuous improvement initiatives while maintaining readiness for audits and line clearance. This on-site role requires strong GMP knowledge and hands-on QA leadership.

Qualifications

• Bachelor's degree in a science field or 3+ years in pharma quality.
• Experience with Batch Records review, audit, and disposition.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S, Eudralex).
• Experience making quality-based decisions under tight timelines.
• Strong written and oral communication skills.
• Certified Quality Auditor (CQA) preferred.

Responsibilities

• Review and approve batch documentation and disposition.
• Provide QA oversight for manufacturing, testing, and line clearance.
• Identify non-conformances and recommend corrective actions.
• Support investigations, deviations, and CAPA processes.
• Collaborate across departments and mentor QA colleagues.
• Participate in GMP audits and customer/regulatory audits.

Skills

Batch record review

Audit

Disposition

Quality oversight

Communication skills

Team collaboration

Education

Bachelor's degree in a science field

Job description

Kindeva Drug Delivery is seeking a QA Specialist I/II to provide advanced quality oversight, evaluate batch documentation, and manage product disposition in a fast-paced manufacturing setting.

You will partner with cross-functional teams to ensure regulatory compliance, lead investigations, and support continuous improvement initiatives while maintaining readiness for audits and line clearance. This on-site role requires strong GMP knowledge and hands-on QA leadership.