Quality Aseptic Supervisor

Job Description

Job Description

The Quality Aseptic Supervisor will report directly to the Microbiology 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 Supervisor 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:

This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

• 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
• Assisting 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 cross functionally 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.

Supervisory Responsibilities:

• Directly hire and lead a team of aseptic specialists.
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
• Conduct regular 1:1’sto address performance, feedback relationship building.
• Identify training and development needs within the team and facilitate as able.

EXPERIENCE AND NECESSARY SKILLS:

• Bachelor’s degree in microbiology or a related scientific field required.
• 1-3+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 (21CFRPart 11/210/211)
• Knowledge of aseptic manufacturing and environmental monitoring processes
• Excellent technical writing skills
• Strong ability to collaborate with a hands-on, proactive, “can-do” attitude
• Ability to train personnel and effectively convey the rationale behind requirements and procedures
• Critical thinking, troubleshooting, and problem-solving abilities
• Effective listener who actively participates in group discussions
• Comfortable working in a fast paced environment, self-motivated and adaptable to changing priorities
• 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.

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• FSA & HSA available
• Dental & Vision insurance options
• 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. 

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.

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.