Aseptic Process Coach – Quality & Operations Liaison

STAQ Pharma; Denver (CO); On-site; USD 70,000 - 95,000; Full time

Job summary

STAQ Pharma seeks an Aseptic Specialist embedded in Manufacturing Operations to promote excellence in aseptic processing and to coach production personnel in validated smoke studies, aseptic techniques, and laminar airflow (LFH) principles.

The role focuses on real-time coaching, adherence to best practices, and collaboration with Quality and Operations to strengthen contamination control and continuous improvement.

Qualifications

• Associate or Bachelor’s degree in life sciences.
• 2+ years of experience in cGMP manufacturing or cleanroom environments.
• Qualified to enter classified manufacturing areas, including gowning qualification.
• Experience with aseptic process simulations (Media Fill).

Responsibilities

• Observe aseptic operations to ensure adherence to validated smoke studies and LFH principles.
• Coach operators in maintaining first air and aseptic techniques.
• Assist with setup of laminar flow hoods and work area organization.
• Monitor personnel sampling and support qualification activities.
• Identify opportunities for process improvements and report trends to Quality and Operations leadership.
• Support investigations, CAPAs, and SOP updates as needed.

Skills

Aseptic processing

GMP compliance

Gowning qualification

Media Fill qualification

First air principles

Observation skills

Technical writing

Coaching/mentoring

Communication skills

Education

Associate or Bachelor's degree in life sciences

Job description

STAQ Pharma seeks an Aseptic Specialist embedded in Manufacturing Operations to promote excellence in aseptic processing and to coach production personnel in validated smoke studies, aseptic techniques, and laminar airflow (LFH) principles.

The role focuses on real-time coaching, adherence to best practices, and collaboration with Quality and Operations to strengthen contamination control and continuous improvement.