QA Specialist I — Aseptic Compliance & Process Improvement

Kindeva; Maryland Heights, Northern (MO, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Kindeva in Missouri Heights is seeking a QA Specialist I to provide quality oversight and regulatory support for manufacturing, including aseptic processing, filling, inspection, and packaging. You will review documentation, monitor processes, and assist investigations under cGMP standards.

Collaborate with cross-functional teams to support continuous improvement, maintain inspection readiness, and participate in audits.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related science.
• Minimum 1 year experience in Pharmaceutical or related industry.
• Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex).
• Experience with incident investigations and CAPAs.
• Team-based and effective communication skills.
• Certified Quality Auditor (CQA) preferred.

Responsibilities

• Review and evaluate manufacturing and testing documentation for SOPs and cGMP compliance.
• Provide quality oversight during shop floor activities and inspections.
• Escalate quality issues and contribute to root cause analysis and corrective actions.
• Collaborate with cross-functional teams on process improvements and regulatory adherence.
• Collect, analyze, and report data to identify trends.
• Assist in training QA colleagues and share best practices.
• Demonstrate proficiency in aseptic techniques in cleanroom areas.
• Review SOPs, logbooks, and batch records for accuracy.

Skills

Quality oversight

cGMP knowledge

Regulatory compliance

Documentation review

Cross-functional collaboration

Audit readiness

Data analysis

Training/mentoring

Education

Bachelor's degree in science

1+ year pharmaceutical experience

Tools

ERP systems

Batch records review

Job description

Kindeva in Missouri Heights is seeking a QA Specialist I to provide quality oversight and regulatory support for manufacturing, including aseptic processing, filling, inspection, and packaging. You will review documentation, monitor processes, and assist investigations under cGMP standards.

Collaborate with cross-functional teams to support continuous improvement, maintain inspection readiness, and participate in audits.