Quality Engineer

This position reports to the Director of Quality Assurance. The Quality Engineer facilitates and/or performs investigations and root cause analyses in order to develop corrective and preventative actions (CAPA) that eliminate current problems and prevent future occurrences. Will assist in developing quality control policies and evaluate production limitations. The candidate should have a strong understanding of cGMP requirements. The position requires an individual who can work both independently and in a team environment, is experienced in cGMP requirements, can implement quality system and process improvements, has a high attention to detail, and has excellent communication skills with other functional areas and sites.

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 quality investigations and supporting activities including:

1. Lead Investigations into Quality Events such as Deviations, Complaints, and Out of Specifications (OOS).
2. Lead cross-functional project teams to implement systems which reduce quality defects and improve compliance (CAPA).
3. Issue Protocols to inspect, test, and evaluate the reliability of manufacturing processes, parts, and equipment.
4. Quality oversight and approval of equipment calibration, maintenance, and validation documents
5. Provide quality guidance, expertise, and services to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
6. Ensure processes adhere to quality standards.
7. Provide quality guidance and service to quality control, R&D, manufacturing engineering, production, procurement, and other departments.
8. Complete quality department assignments with clearly defined objectives.
9. Partner with peers and other departments to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.
10. Create, revise, , and approve documents, deviation records, and maintenance records.
11. Update, track, and trend departmental metrics.
12. Expected to solve problems of limited scope and complexity, seek management guidance as required.
13. Work, within a team setting, to ensure that the systems involved in the facility are in a state of control
14. Other duties as assigned to ensure appropriate quality practices

Supervisory Responsibilities:

• None

Experience & Necessary Skills:

1. Knowledge and experience with the Pharmacy CO Code of Regulations, CO Board of Pharmacies, and US FDA cGMPs, preferably in a commercial compounding outsource facility
2. Knowledge and experience of compounding techniques, controlled environments, and compounding facilities
3. Knowledge of appropriate materials and conditions
4. Able to identify potential adverse issues and drive corrective actions
5. Excellent organization and documentation skills
6. BS or BA degree (in a scientific discipline desired);
7. Knowledge and experience in a cGMP environment in manufacturing/laboratories

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

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.