Boehringer Ingelheim Senior Specialist, Change Control in SAINT JOSEPH, Missouri
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.
The individual will manage all aspects of Change Control, Devise tools to improve the change control procedure to enable data gathering. Create/refine change tracking system and analyze the CCs. This individual will disposition Change Controls as appropriate and assure approved change is in compliance with corporate requirement, EU and USDA requirement. Will track and receive change controls from different areas. Record and maintain change controls and all documentation in the TrackWise system. Following up on overdue and those Change Controls that are coming due to maintain compliance. Maintain and track KPI's tied to change management as well as provide updates to management on progress. Attend Change Control project meetings and provide QA oversight for these Change Controls.
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
Track and Maintain Change Controls in TrackWise system. Follow up on outstanding change controls that have been requested to make sure they get closed out.
Follow up with CC owners to make sure all new CC are completed on time. Track KPI's tied to Change Management and provide updates to department management monthly.
Responsible for managing projects tied to Change Controls and attending necessary meetings as required to provide QA input.
Responsible to learn other systems to include deviation/CAPA, Trackwise and IDEA for CON and be a backup for these systems/functions.
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.
Minimum of a Bachelor’s degree, from an accredited institution, with five plus (5+) years of business experience OR Master’s degree, from an accredited institution, in a relevant scientific field with three plus ( 3)+ years of relevant business experience or a PhD in a relevant scientific discipline.
Good written and communication skills, strong investigative skills required as the position involves investigation involving various products and various departments.
Requires knowledge of vaccine products, manufacturing procedure and processes.
Has sound decision making skills along with ability to take quick actions and excellent attention to detail.
Note : Relevant BIVI experience may be weighted more significantly.
This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.
Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess product, procedures, and recommended improvements to make quality decisions.
Desired Skills, Experience and Abilities:
- Work experience in USDA or European Union (EU) regulated animal health industry required.
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
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 Vetmedica Inc. and Boehringer Ingelheim Fremont, Inc. is an equal opportunity employer. Minority/Female/Protected Veteran/Person with a Disability
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.
Title: Senior Specialist, Change Control
Location: Americas-US-MO-Saint Joseph
Requisition ID: 1814828