Quality Aseptic Specialist

Leiters Inc•Englewood, CO

About The Position

This position will report directly to the Quality Aseptic Manager and play a key role within the Quality team. This position is critical to maintaining sterile and aseptic conditions within Leiters Health’s cleanroom suites. The Specialist will be instrumental in upholding and enhancing the highest standards of aseptic technique and cleanroom behavior among operators involved in sterile compounding. With a focus on rigorous oversight, guidance, process improvement, personnel training, and regulatory compliance, this role ensures the consistent production of safe and sterile compounded products.

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
Proficient in MS Word, Excel, Power Point and related applications
Strong ability to collaborate with scientific and technical personnel
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
Excellent interpersonal, verbal and written communication skills in a collaborative work environment
Comfortable working in a fast-paced, small company setting with minimal supervision, and able to prioritize workload based on shifting demands
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.

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.

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
$1,000 Referral Bonus Program with no limit
Eligible for annual bonus program