Quality Assurance & Analytical Manager

The Quality Assurance & Analytical Manager reports to the Associate Director of Quality and is responsible for the assurance that medications produced by Leiters Health have the safety, identity, strength, purity and quality represented in addition to providing assurance that product labelling is accurate and meets associated cGMP requirements. The candidate must possess a keen understanding of cGMP regulations and have experience managing personnel to these standards.

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 Function:

• Review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures for intended use.
• Approve and monitor analyses carried out under contract through 3rd party private laboratories.
• Monitor the maintenance of the department(s) processes and equipment.
• Investigate reprocessing/rework of products, complaints, analytical failures, deviations, and OOS.
• Achieve quality operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Establish product specifications and quality attributes; writing and updating quality control procedures.
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions, and re-validations.
• Interact effectively with the Leadership Team and contribute to the continued growth and success of the Company through innovative thinking, planning, and implementation of new concepts, products, and services.
• Oversee all Quality Assurance labelling and assurance activities.
• Oversee all Quality Assurance inspection activities post manufacturing labelling and inspection activities (AQL)
• Represent analytical, labelling, and inspection activities during regulatory and customer inspections as required.
• Oversee the hold program and ensures materials are placed on hold / removed from hold in a timely manner to avoid potential incorrect or inappropriate processing of materials.
• Work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control
• Other duties as assigned.

Supervisory Responsibilities:

• Directly hire and lead a team of Analytical and Labeling Associates and Supervisors.
• 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 and relationship building.
• Identify training and development needs within the team and facilitate as able.

Experience and Necessary Skills:

• Bachelor's degree in a related field (preferably in a scientific discipline) or equivalent experience.
• 4+ years of experience working in an FDA-regulated environment, minimum of 3 years of management experience.
• Strategic and analytical thinker, with the ability to examine details and interpret the impact of key business drivers or potential adverse issues.
• Demonstrated knowledge and experience with US FDA cGMP,…