Aseptic Specialist

STAQ Pharma Inc•Denver, CO

1d•$0 - $28•Onsite

About The Position

The Aseptic Specialist is a Quality-owned position embedded within Manufacturing Operations to promote and sustain excellence in aseptic processing. This role serves as a collaborative partner to production personnel, providing real-time coaching, guidance, and oversight to ensure operators consistently perform in accordance with approved smoke studies, aseptic techniques, and laminar airflow (LFH) principles. The Aseptic Specialist is not intended to function as an auditor or inspector, but rather as a technical resource and mentor who works alongside Operations to reinforce best practices, identify opportunities for improvement, and help maintain a robust state of contamination control.

Requirements

Demonstrated knowledge of aseptic processing principles and contamination control.
Qualified to enter classified manufacturing areas, including successful gowning qualification.
Successfully qualified through aseptic process simulation (Media Fill) requirements.
Strong understanding of first air principles, smoke study interpretation, and laminar airflow concepts.
Excellent verbal and written communication skills.
Ability to effectively communicate with personnel at all organizational levels.
Strong interpersonal skills with the ability to coach, mentor, and influence others in a positive and professional manner.
Ability to build trust and maintain strong collaborative relationships between Quality and Operations.
Strong observational skills with attention to detail.
Ability to remain objective while providing constructive feedback.
Excellent technical writing skills for documenting observations, recommendations, and process improvements.

Nice To Haves

Experience working within GMP-regulated pharmaceutical manufacturing preferred.
Associate or Bachelor’s degree in related life sciences.
2+ years of experience in cGMP Manufacturing environment and/or cleanroom setting preferred

Responsibilities

Observe aseptic operations to ensure operator activities remain consistent with validated smoke studies.
Reinforce first air principles and immediately coach operators when practices could disrupt unidirectional airflow.
Promote consistent execution of validated aseptic techniques during all production activities.
Verify proper arrangement of materials, equipment, and supplies within ISO 5 workspaces.
Assist operators in optimizing hood setup to maintain first air and minimize airflow disruption.
Recommend improvements to workstation organization based on smoke study observations and operational efficiency.
Provide immediate, respectful coaching to operators during routine manufacturing activities.
Reinforce proper aseptic behaviors while recognizing and encouraging exemplary technique.
Identify recurring opportunities for improvement and communicate trends to Quality and Operations leadership.
Perform non-biased personnel monitoring, including fingertip and gown sampling.
Ensure personnel monitoring accurately reflects operator performance while maintaining consistency and objectivity.
Assist with qualification and requalification activities for aseptic operators.
Partner with Quality and Operations to improve aseptic processes, workflows, and contamination control practices.
Participate in investigations, CAPAs, risk assessments, smoke study reviews, and contamination control initiatives as needed.
Recommend improvements to Standard Operating Procedures (SOPs), batch records, training materials, and other controlled documents to strengthen compliance and operational efficiency.