Internal Audit Manager

This description is intended to be illustrative of the major duties performed by the employee recruited to this position. Performs other duties as assigned.

General Description:

Performs all facets of internal quality audits, including plan development, initiation, observations/interviews, analysis of results, report compilation/distribution, presentation of results to auditees, approval and verification of corrective/preventive actions, and audit file maintenance verifying the implementation and effectiveness of the processes and procedures used by employees and contractors to meet the requirements of the QMS.

Essential Functions:

• Determine Internal Audit scope, develop, and implement audit annual plan.
• Perform and control the full audit cycle including risk management and control management over operations’ effectiveness, financial reliability and compliance with all applicable directives and regulations.
• Supports third party audits of Leiters Health by government agencies, accreditation/licensing agencies and business partners as needed.
• Manage every aspect of Internal Audit quality system program from audit planning, implementation, feedback and re-audit as required.
• Reviews elements of CAPA investigations for completeness and accuracy, verifies effectiveness of corrective actions, and works with key stakeholders to ensure related documentation adequately resolves the related issue(s)
• Develop training modules for various data quality process sections.
• Serves as a QS technical resource/SME for Quality related activities and provides training as required.
• Assigning team members to quality audits and overseeing their work.
• Training employees in quality standards and procedures.
• Preparing and presenting quality audit reports to senior management.
• Keeping abreast of industry standards and regulations
• Analyze and evaluate Quality and Operation documentation, previous reports, data, flowcharts etc
• Prepare and present reports that reflect audit results and document process.
• Maintain open communication with management and audit committee.
• Document process and prepare audit findings memorandum.
• Conduct follow up audits to monitor management’s interventions.
• Enhance quality across organization and provide stable performance to customers.
• Other duties as assigned to ensure appropriate quality practices.

Experience & Necessary Skills:

• Bachelor’s degree in sciences required, Biology/Microbiology, General Chemistry or Chemical Engineering preferred.
• Certification by a recognized accreditation program (Exemplar Global, Oriel Stat A Matrix, ASQ) as Quality Systems Internal Auditor Lead is a must.
• At least five years' experience as a quality auditor in a related industry. (Pharmaceutical/Devices, 503B) experience preferred.
• In-depth knowledge of industry standards and cGMP requirements (21CFR211)
• Exceptional attention to detail.
• Advanced organizational skills. Able to perform work with little supervision.
• Excellent verbal and written communication skills to make oral presentations and write audits reports.
• Experience leading with FDA, DEA and Sates BOP regulatory requirements Able to work independently and in a team environment.
• Advanced computer skills including proficiency in Microsoft Office (Word, Excel, Power Point).
• Ability to multi-task, with strong organization, time-management, and prioritizing skills.
• Experience preparing a list of deviations for correction and verify corrections as per established company standards.
• Able to lift up to 50lbs and stand for extended periods.
• Willing to work extended hours and complete repetitive tasks.
• Ability to work on your own or within a team environment, with good organizational skills. Detail-oriented.

Benefits:

• Medical, Dental & Vision insurance options including FSA & HAS
• 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: $111,888 - $139,860 annual salary depending on experience

About Leiters Health:

Leiters is a trusted FDA-registered 503B outsourcing provider of high-quality hospital and ophthalmology compounded sterile preparations. We are committed to providing healthcare professionals and their patients with critically needed outsourced medications. Our team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust automated processes, in a state-of-the-art outsourcing facility, to ensure delivery of the highest quality medicines. All sterile preparations are produced under the Human Drug Outsourcing Facilities under 503B of the FD&C Act (503B Guidance) and follow Current Good Manufacturing Practices (cGMP). Leiters. Where Quality Means Something.

Our vision is to make the world a healthier place to live, and that starts with you! We believe everyone can be an impact player. Join Leiters and discover a career, not just a job. Our culture is centered around talent development where employees are given opportunities of growth to make a difference in our company as well as the world. Join Leiters and grow with us as we enter this stage of expansion.

Our foundation at Leiters is built on 5 core values:

Integrity. - Hold yourself and others to the highest standard. Always do the right thing, even when no one is looking. Admit mistakes and take responsibility.

Results Oriented. - Be an impact player. Focus on great results rather than progress. Have a bias for action and consistently demand strong performance.

Passionate. - Care intensely for our mission, vision, and patient care. Inspire others in a quest for excellence.

Innovative. - Be creative and innovative in solving problems and delivering the highest quality products with exceptional customer service. Do not tolerate the status quo.

Collaborative. - Helping and supporting one another. Holding yourself and others accountable to the Company’s mission, vision, values, and goals. Working together with our customers to meet mutual goals.

Celebrate, Foster, and Empower- Diversity, Equity, and Inclusion

Leiters mission to provide better medicine to more people fosters the opportunity to celebrate diversity and empower all members of the organization to be inclusive. Diversity, equity, and inclusion (DE&I) is an integral to our culture and fuels our growth. At Leiters, we are committed to building a team with diversity of thought, experience, background, skills, and culture. We value the unique qualities and skillsets each of our team members bring to our company. The more inclusive we are, the better we perform. Creating and sustaining diversity, equity and inclusion is imperative as we build for success.

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.

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