QA Specialist I — Aseptic Manufacturing & Compliance

Kindeva; Brentwood (MO); On-site; USD 65,000 - 90,000; Full time

Job summary

Kindeva is seeking a QA Specialist I to provide quality oversight and regulatory support across aseptic manufacturing operations, including filling, inspection, and packaging. The role emphasizes cGMP compliance, documentation review, and proactive quality improvements.

The position requires a science degree or equivalent experience, strong analytical and communication skills, and readiness to work on-site. Training, audits, and cross-functional collaboration are key parts of the role.

Qualifications

• Bachelor level science degree and/or 1 year pharma experience.
• Knowledge of cGMP, regulatory requirements, and aseptic processing.
• Ability to perform data analysis, investigations, and CAPA.
• Strong communication and teamwork across functions.

Responsibilities

• Review and evaluate manufacturing and testing documentation for SOPs and cGMP compliance.
• Provide quality oversight during shop floor activities, inspections, deviation investigations, change management, and batch documentation review.
• Identify and elevate quality issues; support root cause analysis and corrective actions.
• Collaborate with cross-functional teams to support process improvements and regulatory adherence.
• Collect, analyze, and report departmental data to identify trends and support continuous improvement.
• Assist in training and mentoring QA colleagues, sharing best practices.
• Demonstrate proficiency in aseptic techniques and aseptic processing areas.
• Apply knowledge of manufacturing operations and quality procedures to influence compliance outcomes.
• Communicate issues identified during batch production or record reviews to management.
• Review and edit SOPs, logbooks, and batch records for accuracy and regulatory alignment.
• Participate in internal GMP audits and support customer/regulatory audits.
• Assist in review/edit of SOPs / Master Batch Records.
• Perform ERP transactions, as applicable.
• Must be willing to work weekends and holidays as needed.

Skills

cGMP knowledge

Regulatory standards

Documentation review

Process monitoring

Root cause analysis

Cross-functional collaboration

Data analysis

Training & mentoring

Aseptic technique

ERP transactions

Education

Bachelor's degree in science (Chemistry/Biology/Microbiology/Pharmacy/Engineering)

1 year pharma/related industry experience

Tools

ERP systems

Job description

Kindeva is seeking a QA Specialist I to provide quality oversight and regulatory support across aseptic manufacturing operations, including filling, inspection, and packaging. The role emphasizes cGMP compliance, documentation review, and proactive quality improvements.

The position requires a science degree or equivalent experience, strong analytical and communication skills, and readiness to work on-site. Training, audits, and cross-functional collaboration are key parts of the role.