Manager, Quality Assurance

in Indianapolis, IN

Manager, Quality Assurance Job

Job Description Job Attributes+

  • Job ID

    0cf0c06c-b7ab-449a-9af2-4934b35c0c11

  • Req #

    20086182

  • Job Location

    7736 Zionsville Rd
    Indianapolis, IN 46268, US

  • Job Category

    Quality

  • Job Type

    Regular

  • Schedule

    Full time

What Quality Assurance contributes to Cardinal Health
Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.

Demonstrates knowledge of quality systems and approaches.Demonstrates an understanding of the relevant regulations, standards and operating procedures.Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Accountabilities

Responsible for the release of final product before distribution to the market, including submission (by ensuring preparation of the adequate documentation) of the product.As the head of the Quality Assurance team, ensure release of the final product in compliance with Good Manufacturing Practices, with the marketing authorization and regulatory requirements.Manages deviations related to final product packaging components and/or raw materials disposition (e.g. root cause analysis, CAPA plan identification and follow-up) in a timely manner.Ensures CAPAs for which the team is responsible are followed and closed within defined timelines.Reviews, comments and challenges in an appropriate way, the Product Quality Reviews for the product with the team’s responsibility.  In that context, has the knowledge of the production process of the product.Understands technical/release product issue and evaluate their potential impact on product quality and compliance.Escalates complex issues to management in a timely manner.Responsible to manage a small team of employees.Prioritizes and ensures work is delivered in an efficient way.Provides daily problem solving.Represents QA in meeting related to his/her area of responsibility (product tree meeting, deviations, change control, stability planning and review, validations, etc.).Performs other duties as assigned.

Qualifications

Bachelor's degree in Chemistry, Biology, or related science field preferred5+ years of relevant work experience in Quality Assurance, working with 21 CFR 210 and 211 and external Regulatory body regulationsExperience leading regulatory inspections is preferredMust work well with others and understand how to be successful in a Team environmentMust be detail oriented, organized, able to multi-task, a self-starter, and self-motivatedMust be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills

What is expected of you and others at this level

Manages professional employees and/or supervisors. Applies expertise to improve effectiveness and provide guidance to employees in own areaParticipates in the development of policies and procedures to achieve specific goalsEnsures employees operate within guidelinesDecisions have a short term impact on work processes, outcomes, and customersInteracts with subordinates, peer customers and suppliers at various management levels; may interact with senior managementInteractions normally involves resolution of issues related to operations and/or projectsGains consensus from various parties involved

Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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