Aseptic Compliance Specialist

GTT•Thousand Oaks, CA

3d•Onsite

About The Position

The Aseptic Compliance Specialist serves as a technical resource for drug product aseptic processing in a drug production facility supporting 24/7 manufacturing. The role focuses on data review, compliance, continuous improvement, and development of media fill protocols. The position is onsite in Thousand Oaks, California, and is a 12-month contract. The initial schedule is Monday–Friday, 8:00 AM–5:00 PM; once 24/7 operations commence in 2027, the schedule transitions to Wednesday–Sunday, 8:00 AM–5:00 PM. The specialist supports aseptic operations on the manufacturing floor, owns aseptic-related deviations, performs compliance reviews, and revises controlled documents. The role also analyzes operational data to identify trends, risks, and bottlenecks; develops metrics and actionable outputs; and collaborates with the 24/7 operational readiness team. Media fill protocol work includes defining scope, batch size, interventions, acceptance criteria, and incubation conditions. Applicants must be authorized to work for any employer in the United States. The employer cannot sponsor or take over sponsorship of an employment visa. Interviews consist of an initial recruiter phone screen followed by interviews with the hiring team.

Requirements

Hands-on experience with aseptic practices and drug product filling; familiarity alone is insufficient.
Drug product manufacturing experience.
Aseptic compliance or contamination control experience.
Outstanding communication skills.
Project management experience within drug production or manufacturing; sterile or aseptic environment experience is strongly preferred.
Hands-on experience with media fill or aseptic process simulation activities.
Demonstrated experience in CAPA reviews (corrective and preventive actions) or similar quality/compliance investigations.
Education and experience must meet one of the following: doctorate degree; master's degree and 2 years of experience; bachelor's degree and 4 years of experience; associate's degree and 8 years of experience; or high school diploma/GED and 10 years of experience.
Must be authorized to work for any employer in the United States; visa sponsorship or transfer is not available.

Nice To Haves

Prior involvement in 24/7 operational readiness or continuous manufacturing operations.
Familiarity with FDA/EMA regulatory expectations for aseptic processing and GMP documentation practices.
Experience in a sterile or aseptic manufacturing environment.

Responsibilities

Serve as a drug product aseptic processing technical resource supporting 24/7 drug product manufacturing.
Support continuous improvement initiatives to strengthen aseptic compliance, process robustness, and operational efficiency.
Revise controlled documents, including SOPs, work instructions, and related records, to support process changes and improvements.
Own aseptic-related deviations.
Evaluate at least one year of aseptic call log data from the manufacturing floor to identify recurring trends, root causes, and improvement opportunities.
Develop metrics, summaries, and actionable outputs that translate operational data into decisions, priorities, and follow-up actions.
Establish and maintain a cyclical process for gathering information, addressing challenges, implementing improvements, and assessing effectiveness.
Analyze production data to identify bottlenecks and risks for 24/7 operations planned for 2027.
Write reports and perform compliance reviews related to aseptic manufacturing.
Collaborate with the 24/7 operational readiness team.
Prepare media fill protocols, including scope, batch size, interventions, acceptance criteria, and incubation conditions.
Provide on-the-floor support during aseptic operations.
Manage completion of metrics and actionable outputs.