Quality Aseptic Specialist - 3rd Shift

About the role

The Quality Aseptic Specialist reports directly to the Quality Aseptic Manager and plays a key role within the Quality team. This position is critical to maintaining sterile and aseptic conditions within Leiters Health’s cleanroom suites.

Responsibilities

• Monitor operators and personnel in real-time during sterile compounding to ensure strict adherence to aseptic techniques and cleanroom protocols.
• Enforce compliance with proper gowning, cleanroom behavior, material transfer, and aseptic practices within cleanroom environments.
• Conduct detailed inspections of operators, equipment, and facilities to verify compliance with cleanroom standards and aseptic procedures.
• Provide ongoing training and guidance to operators on best practices for aseptic technique, cleanroom behavior, and contamination prevention while fostering a culture of accountability and excellence.
• Assist in investigations regarding aseptic technique breaches and deviations from cleanroom procedures, working closely with cross-functional teams to identify root causes and implement effective corrective actions.
• Collaborate with Quality, Training, Facilities, Engineering, and Operational teams to identify and implement process improvements that enhance aseptic practices and ensure product integrity.
• Stay current on industry regulations and guidelines related to sterile compounding, ensuring all practices and procedures align with relevant standards and compliance measures.
• Administer assessments for sterile gowning, aseptic technique, and cleanroom behavior to ensure personnel maintain necessary qualifications.
• Maintain personnel qualification program including gowning qualifications, aseptic assessments, relevant training, and media fill qualifications.
• Develop and update standard operating procedures, forms, job aids, and training materials to support consistent and compliant practices.

Requirements

• Bachelor’s degree in microbiology or a related scientific field required with 2+ years of experience in the biotech and/or pharmaceutical industry.
• Experience with aseptic technique, sterile gowning, and cleanroom operations.
• Experience identifying, writing, evaluating, and closing deviation investigations.
• Knowledge of regulatory requirements for aseptic operations and sterile drug product manufacturing.
• Knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
• Knowledge of aseptic manufacturing and environmental monitoring processes.
• Knowledge of cGMP and quality processes.
• Excellent technical writing skills.
• Strong ability to collaborate with scientific and technical personnel.
• Strong ability to train personnel and effectively convey the rationale behind requirements and procedures.
• Critical thinking, troubleshooting, and problem-solving abilities.
• Hands-on approach with a proactive, “can-do” attitude.
• Effective listener who actively participates in group discussions.
• Self-motivated, adaptable, and willing to take on temporary responsibilities outside of initial job scope.
• Comfortable working in a fast-paced, small company setting with minimal supervision, and able to prioritize workload based on shifting demands.
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

Qualifications

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically.
• Ability to maintain a gowning qualification for ISO 7 cleanroom environments.

Skills

• Technical writing skills.
• Collaboration with scientific and technical personnel.
• Training personnel and conveying rationale.
• Critical thinking and problem-solving.
• Hands-on approach and proactive attitude.
• Effective communication skills.
• Microsoft 365 proficiency.

Benefits

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• Referral Bonus Program with no limit
• Eligible for annual bonus program

Pay

Base Salary + 25% differential

Schedule

11:30pm - 8:00am