Job Information
McKesson Corporation Validation Manager in Mason, Ohio
Position Summary (Purpose of job): The Validation Manager ensures the McKesson 3PL facilities and equipment used for storage and transport of pharmaceutical products are maintained in a state of validation, maintenance, and calibration. Has oversight and helps ensure the creation and execution of protocols for testing and periodic evaluation of equipment and facilities. Key Responsibilities Author, review, and approve technical documentation, protocols, and reports. This includes but is not limited to DQ/IQ/OQ/PQ protocols as well as supporting change controls related to equipment and facilities. Supports equipment and facility installation, qualification and requalification Stays current with changes to GMP, including FDA, EU, and other regulatory bodies regarding validation requirements and maintains the program to evolving standards. Coordinates calibration of temperature monitoring equipment and other similar equipment used for measurement of goods. Reviews calibration records to ensure calibration of all equipment is carried out as per procedure. Ensures any out of tolerance equipment is replaced or repaired, accordingly. Reviews maintenance records, temperature data, operational data, and other similar records, as per procedure, as part of periodic reviews to ensure equipment is kept in a state of repair and fit for use. Participate in quality and process improvement initiatives and project teams related to validation. Participate as needed to support Client and Regulatory audits. Minimum Job Qualifications (Knowledge, Skills, & Abilities): Education/Training - Associates/Four- year degree and/or equivalent experience. Business Experience - 3 years validation experience, required. Familiarity of Kaye Validator equipment preferred. Quality Management System and/or Document control management experience, preferred. Knowledge of calibration standards, such as ISO 17025, preferred. Knowledge of pharmaceutical regulations, including FDA requirements, preferred. Knowledge of MasterControl, preferred. Specialized Knowledge/Skills - 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. 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 supportphysical, 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 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 $75,500 - $125,900 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