General Description:

This position will report to the Site Quality Manager. The Quality Supervisor evaluates, tracks, trends, and monitors the Quality Assurance and Control activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites. Moreover, the role is responsible for promoting our mission of improving patient outcomes with high quality outsourced pharmaceuticals.

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.

Why Join Leiters Health?

• 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:

• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
• Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures.
• Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning.
• Review and approve criteria for analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are performed.
• Review and approve maintenance activities for processes and equipment.
• Ensure that the required initial and continuing training of personnel is carried out and adapted according to need
• Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages
• Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
• Supporting or performing internal audits.
• Supporting external regulatory or customer audits.
• Gather information from multiple departments for trending and presentation to management.
• Identify trends in the industry and recommend improvements
• Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control
• Other duties as assigned to ensure appropriate quality practices

SUPERVISORY RESPONSIBILITIES:

• Supervise Quality technicians

EXPERIENCE AND NECESSARY SKILLS:

• Knowledge and experience with the cGMPs, preferably in a commercial compounding outsource facility
• Able to identify potential adverse issues
• Excellent organization and documentation skills
• Detail oriented
• Computer skills, including Microsoft Word and Excel
• BS or BA degree (in a scientific discipline desired)

Benefits:

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

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.