Aseptic Compliance Specialist

Aseptic Compliance Specialist

Location: Thousand Oaks, CA

Onsite Flexibility

Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $32.00 $38.00 / Hour (USD)
• Shift / Schedule: Monday Friday, 8:00 AM 5:00 PM initially; transitioning to Wednesday Sunday, 8:00 AM 5:00 PM once 24/7 operations commence in 2027
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

Candidates must have experience with aseptic practices and drug product filling. Suppliers must screen for this experience beyond familiarity. This role serves as a drug product aseptic processing technical resource supporting 24/7 drug product manufacturing. The function focuses on data review, compliance, and media fill protocol development within a drug production facility.

Key Responsibilities

• Serve as a drug product aseptic processing technical resource supporting 24/7 drug product manufacturing.
• Support continuous improvement initiatives that 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.
• Support the 24/7 Ways of Working Lead to evaluate 1 years of aseptic call log data from the floor and identify recurring trends, root causes, and improvement opportunities.
• Develop clear metrics, summaries, and actionable outputs that convert operational data into decisions, priorities, and follow-up actions.
• Establish and maintain a cyclic process for gathering information, addressing challenges, implementing improvements, and assessing effectiveness.
• Analyze production data to identify bottlenecks and risks for 24/7 operations in 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.
• Develop metrics, actionable outputs, and manage completion of those outputs.

Required Skills

• Experience with aseptic practices and drug product filling (beyond familiarity must be hands-on)
• Drug product manufacturing experience
• Aseptic compliance/contamination control experience
• Outstanding communication skills

Preferred Skills

• Prior involvement in 24/7 operational readiness or continuous manufacturing operations
• Familiarity with regulatory expectations for aseptic processing (FDA/EMA) and GMP documentation practices

Education Requirements

• Doctorate degree; OR
• Master's degree and 2 years of experience; OR
• Bachelor's degree and 4 years of experience; OR
• Associate's degree and 8 years of experience; OR
• High school diploma / GED and 10 years of experience

Required Experience

• Project management within drug production/manufacturing (sterile or aseptic environment strongly preferred)
• Hands-on experience with media fill / aseptic process simulation activities
• Demonstrated experience in CAPA reviews (corrective and preventive actions) or similar quality/compliance investigations

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Interview process: Phone/virtual interviews initial phone screen conducted by the recruiter, followed by interviews with the hiring team.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16998 Industry: Manufacturing & Operations

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