Boehringer Ingelheim Vetmedica, Inc. is currently seeking a talented and innovative Senior Specialist, CSVC to join our Quality Assurance department located at our St. Joseph, MO facility. As a Senior Specialist, CSVC you will provide company-wide support to the preparation, execution, review and approval of computerized system validation programs, protocols, procedures and policies to assure GxP regulatory compliance.
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:
Drafts, reviews, and approves validation documents for GxP computerized systems, and relevant infrastructure.
Drafts, reviews, and approves SOPs and Forms in support of Computerized System Validation and Compliance (CSVC) business processes.
Executes or directs the execution of validation testing, including change control, to impacted computerized systems.
Manage the activities of external consultants to complete CSVC projects including the review and approval of vendor supplied documentation.
Will lead/train cross-functional teams, with special support to IT, in CSVC activities
Be a resource to the entire organization for GxP computerized system use
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI's excellent reputation in the community.
BS degree in science or a related discipline with a minimum 5 years of relevant and productive experience in a related industry, or MS in related discipline with at least two years of relevant work experience.
Desired Experience, Skills and Abilities:
Excellence in comprehension and application of USDA and EU regulatory requirements for the production and distribution of regulated biological articles.
Strong theoretical and practical knowledge of regulated process, production of biological regulated articles and one technical discipline such as biology.
Demonstrated ability to work in a team environment.
Attention to detail.
Exceptional logical skills with excellence in writing and verbal communication.
Thorough understanding of GxP requirements, EU Annex 11 and 21 CFR Part 11 regulations.
Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC).
Must be legally authorized to work in the United States without restriction.
Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
Must be willing to take a drug test and post-offer physical (if required)
Must be 18 years of age or older
Boehringer Ingelheim is a different kind of pharmaceutical company, a privately held company with the ability to have an innovative and long term view. Our focus is on scientific discoveries that improve patients' lives and we equate success as a pharmaceutical company with the steady introduction of truly innovative medicines. Boehringer Ingelheim is the largest privately held pharmaceutical corporation in the world and ranks among the world's 20 leading pharmaceutical corporations. At Boehringer Ingelheim, we are committed to delivering value through innovation. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings.
Boehringer Ingelheim - 2 years ago
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As the US headquarters of German drug maker Boehringer Ingelheim, Boehringer Ingelheim Corporation oversees about half a dozen stateside...