Aseptic Operations Coach

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

Job summary

STAQ Pharma Inc seeks an Aseptic Specialist to join Manufacturing Operations in Denver, CO. You will partner with production to coach operators, reinforce aseptic techniques, and ensure compliance with smoke studies and laminar airflow principles.

The role emphasizes real-time guidance, continuous process improvement, and collaboration with Quality and Operations to uphold sterility and GMP standards in a fast-paced pharmaceutical environment.

Qualifications

• Demonstrated knowledge of aseptic processing and contamination control.
• Qualified to enter classified manufacturing areas (gowning qualification).
• Qualified through aseptic process simulation (Media Fill).
• Strong understanding of first air principles, smoke studies, and laminar airflow.

Responsibilities

• Observe operations to ensure compliance with validated smoke studies and first air principles.
• Assist with LFH setup and optimize hood configuration for aseptic workspaces.
• Provide real-time coaching to operators during routine manufacturing activities.
• Identify improvement opportunities and communicate trends to Quality and Operations leadership.
• Participate in investigations, CAPAs, risk assessments, and SOP/batch record updates to strengthen compliance.

Skills

Verbal and written communication

Interpersonal skills

Coaching and mentoring

Observational skills

Technical writing

Collaboration with Quality and Ops

Education

Associate or Bachelor’s in life sciences

2+ years in cGMP/manufacturing or cleanroom

Job description

STAQ Pharma Inc seeks an Aseptic Specialist to join Manufacturing Operations in Denver, CO. You will partner with production to coach operators, reinforce aseptic techniques, and ensure compliance with smoke studies and laminar airflow principles.

The role emphasizes real-time guidance, continuous process improvement, and collaboration with Quality and Operations to uphold sterility and GMP standards in a fast-paced pharmaceutical environment.