This position reports directly to Production Management or a designated Site Manager, as assigned. The role is responsible for the preparation, manufacturing, packaging and completion of corresponding documentation of sterile drug product(s) and maintaining quality aseptic area(s) within an outsourcing facility.

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:

Responsible for sterile drug preparation and supporting activities including:

• Operate all formulation, sterile filling, inspection and final vial packaging equipment.
• Aseptically perform and support manual filling activities within a cleanroom environment.
• Follow SOPs, product batch record instructions, and corresponding quality documentation in detail.
• Prepare and maintain accurate documentation following cGMP principles.
• Perform manual inspection of empty vials and filled product with a focus on quality and efficiency.
• Ensure proper accountability and traceability of components, ingredients, and finished products.
• Report and make recommendations regarding equipment, facilities, supplies, required repairs, process concerns, safety concerns and areas for improvement in quality, yield and efficiency.
• Recognize inappropriate directions and/or equipment operation and notify management accordingly.
• Utilizing and handling appropriate supplies and raw materials for proper aseptic manufacturing.
• Support equipment calibration, equipment/utility validation, and preventive maintenance.
• Perform appropriate aseptic gowning.
• Clean and disinfect cleanrooms, equipment, and supplies in support of routine production.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications.
• Adhere to all facility safety policies and procedures and proactively identify unsafe conditions.
• Other duties as assigned.
• Be able to lift up to 50 lbs. and stand for extended periods of time when required.

Experience & Skills Necessary:

• Ability to read, write, and comprehend English
• Understanding of scientific formulations, aseptic techniques/environments and cGMP requirements preferred
• High school diploma or GED required
• Experience in a manufacturing environment or healthcare industry preferred
• Knowledge of materials and techniques used in sterile manufacturing, cleaning and gowning preferred
• Knowledge of and familiarity with controlled environment equipment and area(s)
• High integrity and the ability to work in changing environment
• Good interpersonal and communication skills, both verbal and written
• Willing to work extended hours, complete repetitive tasks and stand for prolonged periods of time
• Ability to work on your own or within a team environment, with good organizational skills. Detail oriented.
• Certification of recent (less than one year) eye exam with minimum 20/30 vision

Benefits:

• 100% employer paid medical plan.
• Dental & Vision insurance options including FSA & HSA
• 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

Pay: $2 shift differential added to base pay for 2nd shift schedules ONLY

Schedules:

• 2nd Shift: Monday - Thursday (3:30pm - 2am)
• 2nd Shift: Wednesday - Saturday (3:30pm - 2am)

Timeline: We will be accepting applications on and 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.