Supplier Quality Specialist II

Supplier Quality Specialist II

This position will report to the Supplier Quality Supervisor. The Supplier Quality Specialist II ensures that all suppliers and vendors meet regulatory requirements and company quality standards. This position will be involved in supplier qualification, evaluation, and monitoring to maintain the quality and safety of components, raw materials, and services utilized at the facility. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, attention to detail, and excellent communication 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:

• Assist the Supplier Quality Supervisor in developing and maintaining the site’s supplier quality system in compliance with cGMP requirements.
• Involvement in the supplier qualification process by approving or not approving new and existing suppliers based on performance and compliance.
• Coordinate and conduct onsite and desktop supplier audits to assess compliance with GMP, FDA, ISO, and other regulatory and quality standards.
• Identify and report nonconformances identified during audits, and work with suppliers to implement CAPA plans.
• Ensure timely resolution of audit findings and maintain recordkeeping of audit outcomes.
• Assist with maintaining the approved supplier list.
• Assist with managing supplier quality agreements.
• Ensure all supplier documentation is accurate, complete, and in compliance with regulatory standards.
• Assess and evaluate supplier risk, performance, and quality systems.
• Collaborate with Supply Chain to ensure that raw materials and components meet internal specifications.
• Investigate and resolve quality issues related to supplier materials, including issuing SCARs when appropriate.
• Author deviations, change controls, and CAPAs related to the supplier quality program.
• Analyze supplier performance metrics and trends to identify areas for improvement.
• Support regulatory inspections and customer audits related to supplier quality management.
• Collaborate with cross-functional teams, including Supply Chain, manufacturing, R&D, and Quality to address supplier-related quality issues and concerns.
• This position will require traveling up to 25% of the time to supplier locations.
• Other duties as assigned.

Supervisory Responsibilities:

• None.

Experience and Necessary Skills:

• Bachelor’s degree in a scientific discipline or commensurate experience required.
• Minimum of 3 years of experience working in an FDA-regulated environment required.
• Quality auditor certification (e.g., ASQ Certified Quality Auditor) preferred.
• Knowledge of compounding techniques and controlled environments.
• Familiarity with material testing methods and quality procedures.
• Detail-oriented with a strong ability to identify nonconformance and resolve issues in a timely manner.
• Strong organizational skills and attention to detail with the ability to manage multiple tasks efficiently.
• Proficiency with Microsoft Office Suite (Word, Excel, etc.) and ERP software.
• Verbal, written and oral proficiency in English language required.
• Able to lift up to 20 lbs and stand or sit for extended periods of time when required.

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

Shift: Monday-Friday 1st

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.