Aseptic Compliance Specialist

Location: Thousand Oaks CA

Onsite

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $32.00$38.00 / Hour (USD)
• Shift / Schedule: MondayFriday 8:00 AM5:00 PM initially; transitioning to WednesdaySunday 8:00 AM5:00 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.

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.

• 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.

• 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

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

• Doctorate degree; OR
• Masters degree and 2 years of experience; OR
• Bachelors degree and 4 years of experience; OR
• Associates degree and 8 years of experience; OR
• High school diploma / GED and 10 years of 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

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

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

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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