Aseptic Operations Quality Associate

Job Title : Aseptic Operations Quality Associate

Location : Greater St. Louis, MO (Hybrid)

Experience : 5 - 8 Years

Contract : 12+ Months

Job Summary

This role centers on supporting sterile compounding operations with a strong focus on quality, compliance, and documentation. You'll help strengthen manufacturing controls, improve batch record accuracy, and ensure procedures reflect current standards. What this really means is you'll be the person who keeps the production floor aligned with regulatory expectations while guiding teams on best practices in sterile technique, gowning, and documentation.

Key Responsibilities

Review, revise, and write SOPs tied to sterile compounding, manufacturing, quality, and documentation practices

Evaluate batch records, manufacturing records, and related documentation for accuracy, completeness, and compliance

Support sterile compounding activities by ensuring adherence to aseptic technique and cleanroom standards

Perform or oversee gowning, visual inspections, and related quality checks

Partner with production and quality teams to troubleshoot deviations or gaps in compounding workflows

Assist in maintaining alignment with applicable regulations, compounding standards, and internal quality expectations

Provide on-floor support during compounding sessions when needed

Contribute to continuous improvement efforts that enhance quality and consistency across operations

Required Experience & Skills

Hands-on sterile compounding experience (503A or 503B preferred but not required)

Strong understanding of aseptic technique, gowning qualification, and cleanroom behavior

Experience reviewing SOPs, batch records, and manufacturing documentation

Familiarity with visual inspection practices

Ability to spot gaps in processes and recommend practical fixes

Clear communication skills with both QA and Operations teams

Ability to work in a hybrid schedule with some on-site support required