What are the responsibilities and job description for the SR Specialist, Change Control position at Boehringer Ingelheim?
Description
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 back up 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 BIAH´s excellent reputation in the community.
Requirements
Minimum of a BS degree from an accredited institution, with five-plus (5 ) years of business experience; Or MS degree from an accredited institution in a relevant scientific field, with three-plus (3 ) years of relevant business experience; or a PhD from an accredited institution 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.
Work experience in USDA or European Union (EU) regulated animal health industry required.
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.
Requires the individual to have expertise in computer applications to include Microsoft suite, IDEA for Con, TrackWise, SAP and other relevant applications.
Familiarity with EU regulations.
Influencing the understanding of GMP´s, compliance requirements, and regulatory requirements to assess product, procedures, recommended improvements to make quality decisions.
Note : Relevant BIAH experience may be weighted more significantly.
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.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
