Validation Specialist I, Quality Systems

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Location :
Columbia, Missouri

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Company Overview Company Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In 2019, Eurofins generated total revenues of EUR 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years. Eurofins BioPharma Product Testing-Columbia has delivered expert scientific support to companies working to improve human and animal health. As a member of the Eurofins BPT Columbia team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Job Description Eurofins BPT-Columbia is looking for a Validation Specialist I to join our Quality Systems team located in Columbia, Missouri. The Validation Specialist I will have responsibility for computer system validation activities. This will include working closely with the Part 11 Team, QA, the validation teams, and Quality Engineering to assure compliance with US FDA regulations, as well as Eurofins BioPharma Product Testing Columbia, and Eurofins corporate policies and procedures. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Duties and Responsibilities include: – Project manage computer system validation activities. – Prepare validation protocols and reports. – Must become and remain an expert on Pharmaceutical Data Systems Data Integrity. – Must rapidly become current and remain expert on the regulatory requirements pertaining to computer systems used in the manufacture and testing of pharmaceutical products. – Maintain validation documentation to ensure timely retrieval in support of client and regulatory audits. – Assist in preparation and maintenance of quality system support documentation, including, but not limited to, computer system validation SOPs. – Performs other related duties as required and directed. The ideal candidate would possess: – Strong computer, scientific, and organizational skills – Excellent communication (oral and written) and attention to detail – Ability to read, analyze, and interpret the most complex documents. Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. – Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors – Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. – Ability to apply critical thinking when developing validation documentation, working with laboratory systems and managing all aspect of the position. – Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies – To perform this job successfully, an individual will need to gain knowledge of a variety of laboratory software systems, spreadsheet software, and word Processing software. – Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Qualifications – Bachelor’s degree in Computer Science or science field and two years of experience providing support to pharmaceutical manufacturing. – Knowledge of 21CFR 210, 211, 58, and Part 11. – Computer System validation in an FDA regulated environment. – Must be an accomplished project manager. – Must be able to multi task and adjust rapidly to new priorities. – BS/BA in Computer Science or science field. – 2 years’ experience providing support to pharmaceutical manufacturing. – CRO experience – Authorization to work in the United States indefinitely without restriction or sponsorship. Additional Information Position is full-time, Monday-Friday, 8 a.m.-4:30 p.m., with overtime as needed. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and PTO, and dental and vision options. To learn more about Eurofins, please explore our website . Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. We are looking forward to receiving your application including your expected salary and possible start date via our career website. Recommended skills Adaptability Persuasive Skills Coordinating Critical Thinking Attention To Detail Title 21 Of The Code Of Federal Regulations