Audit Manager

Summary of Purpose: The Quality Audit Manager ensures the organizational processes and the goods and services that result comply with applicable standards, as well as client, regulatory, and the organizational requirements at the Kentucky and Ohio 3PL facilities. This includes making recommendations for changes to procedures and processes.

Duties and Responsibilities:

• Coordinates and develops internal audit processes, including developing internal audit plans and audit schedules.
• Audit operational and quality processes for compliance with applicable regulatory and client requirements as per the internal audit plans and schedules.
• Manages external audits to ensure that the company is in compliance with client requirements and in compliance with FDA regulations for all services provided. This also includes ISO9001 and other external audits, including vendor audits.
• Collaborates with applicable department leaders to develop corrective actions and responses to audit findings from internal and external audits.
• Submits responses to external auditors using the prescribed response method defined by the auditor or internal procedure.
• Performs random packaging audits to ensure correct packaging was utilized for outbound shipments, as well audits of packaging components to ensure proper storage was maintained.
• Prepares and presents quality audit reports to senior leadership to support management review activities.

Other Duties and Responsibilities: Other duties and responsibilities as assigned by manager.

Minimum Education Required: Two-year associates degree and/or equivalent experience. Certified Quality Auditor preferred.

Minimum Experience Required: 1-3 years quality auditing experience. 3-5 years in a pharmaceutical quality/regulatory environment preferred.

Knowledge, Skills, and Abilities Required (except where noted as preferred): Ability to express ideas clearly both in written and oral communications. Ability to enter data accurately. Ability to handle multiple tasks well. Detail-oriented individual with thorough knowledge of word processing, database, and spreadsheet programs (preferably MS Office). Must possess the ability to work with internal departments to accomplish objectives and meet established deadlines. Must be personable, self-starter, possess a good attitude, and enjoy external and internal contact on the phone and in person with supervisors, co-workers, customers, and potential clients.

Physical Requirements: May sit, stand, stoop, bend, and walk intermittently during the day. Must have the ability to life up to twenty-five (25) pounds, on occasion. Must be able to work/function effectively in temperatures ranging 2-25 Celsius and retrieve packaging materials from a -25 Celsius freezer.

Travel Requirements: Ability to travel between product storage facilities within Kentucky and Ohio, as needed. As well as to vendor sites, as needed.

At CoverMyMeds, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at CoverMyMeds, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position

CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.