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Principal Specialist, Quality Systems

Company: Boehringer Ingelheim
Location: Saint Joseph
Posted on: September 10, 2019

Job Description:

Principal Specialist, Quality Systems Description: The position is responsible for preparation and managing the the annual product reviews quality system. This individual will prepare and/or evaluate data for trends associated to the annual product reviews. This position is also responsible for managing the product quality complaint quality system and investigating product quality complaints and logistic deviations. The position is also responsible for approving all site Corrective Action & Preventative Action plans, and compiling KPIs for site management. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities: - Independently prepares the annual product reviews and data trend analysis. Ensures all other areas that contribute to the annual product review process provides the required data prior to the due date. - Assist with internal, regulatory or Corporate audits to ensure compliance with domestic and international regulations, quality requirements and guidance documents. - Lead projects and ensure department and individual priorities are aligned with corporate, operational and functional priorities. - Track and complete product quality complaints and logistic deviations in the electronic system. Complete assigned complaint investigations and logistic investigations by due date. - Responsible for managing the quality system for annual product reviews, product quality complaints, and logistic deviations. - Development and maintenance of KPIs and applicable monthly reports; manage continuous process improvement initiatives. Requirements: - Minimum of a Bachelor's degree from an accredited institution in a relevant scientific field with eight-plus (8+) years of GxP experience - Work experience in a regulated GxP industry required. - In depth understanding of regulatory and corporate requirements, cGMPs, technical writing and root cause analysis. - Influencing the understanding of cGMP's, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions. Eligibility Requirements: - Must be legally authorized to work in the United States without restriction. - Must be willing to take a drug test and post-offer physical (if required) - Must be 18 years of age or older Who We Are: At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth. Want to learn more? Visit ************************ and join us in our effort to make more health. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law. Quality/Compliance Americas-US-MO-Saint Joseph US-Boehringer Ingelheim Animal Health Full-time

Keywords: Boehringer Ingelheim, Saint Joseph , Principal Specialist, Quality Systems, Other , Saint Joseph, Missouri

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