Quality Aseptic Specialist - 3rd Shift

Job Description

Job Description

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. 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.

Why Join Leiters Health? 

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team! 

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do. 

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For: 

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today! 

Essential Functions:

• 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. 
• Other duties as assigned.

Experience and Necessary Skills:

• 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
• 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. 

Physical Requirements:

• 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.

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 

Timeline: We will be accepting applications on an ongoing basis until position is filled.  

Schedule: 11:30pm - 8:00am 

Pay:  Base Salary + 25% differential

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.