Onsite Quality Assurance Specialist I

Kindeva; Maryland Heights (MO); On-site; USD 60,000 - 80,000; Full time

Job summary

Kindeva seeks a QA Specialist I to provide quality oversight and compliance support across manufacturing operations including aseptic processing, filling, inspection and packaging. You will review documentation for cGMP compliance, support investigations, participate in audits, and collaborate with cross-functional teams to drive continuous improvement and ensure batch integrity.

This role requires a strong foundation in quality systems, SOPs, and data analysis, plus readiness to work

Qualifications

• Bachelor’s degree in a science-related field or 1 year in pharma/related industry.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S).
• Experience with SOPs, batch documentation and change control.
• Strong written and oral communication skills.
• Certified Quality Auditor (CQA) preferred.

Responsibilities

• Review manufacturing and testing documentation for compliance with SOPs and cGMP.
• Provide quality oversight during shop floor activities and inspections.
• Identify and escalate quality issues; support root cause analysis.
• Collaborate with cross-functional teams to drive process improvements.
• Collect, analyze, and report data to identify trends and improvements.
• Assist in training QA colleagues and promote aseptic techniques.
• Participate in internal GMP audits and support external audits.
• Perform ERP transactions as applicable and support investigations.

Skills

Written & verbal communication

cGMP knowledge

Quality auditing

Data analysis

Team collaboration

Incident investigation mindset

Education

Bachelor's degree in Chemistry / Biology / Microbiology / Pharmacy / Engineering

Job description

Kindeva seeks a QA Specialist I to provide quality oversight and compliance support across manufacturing operations including aseptic processing, filling, inspection and packaging. You will review documentation for cGMP compliance, support investigations, participate in audits, and collaborate with cross-functional teams to drive continuous improvement and ensure batch integrity.

This role requires a strong foundation in quality systems, SOPs, and data analysis, plus readiness to work