Boehringer Ingelheim Senior Specialist, QA - APR - Specs 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 responsibility for key QA functions including but not limited to: The Providing feedback and evaluation of quality standards for raw materials/components, intermediates and final products. Preparation of annual product reviews and trend analysis of data from reviews as well as collaboration with other groups to get required data for completion of APR's and compiling all information. Oversee the APR process and make improvements as identified. Assist with management of change control system related to vendor change notifications and implement associated Change Controls. Monitor change notifications and SAS process and track KPI's relevant to completing implementation of revisions. Ensure change notifications from vendors are in compliance with corporate, EU and USDA requirements and do not impact registration. Represent QA on relevant projects and attend regular meetings to provide QA input.
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
Evaluation and maintenance of quality standards for raw materials, intermediates and final products. This includes evaluation and incorporation of changes to compendial changes to specifications and including impact analysis of dossier requirements
Preparation of annual product reviews and trend analysis of data from reviews. Also collaborate with other areas to get required data for completion of APR's by timelines.
Provide QA input on projects and attend necessary meetings to make sure all quality requirements are met to make sure we maintain compliance.
Assist with training to other groups on APR process and requirements for providing information to complete the APR's by assigned timelines. Assist with training other QA specialists and give daily guidance for APR or Change Notifications and SAS's that may come up.
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 a Master’s degree, from an accredited institution, in a relevant scientific field with three (3+) years of relevant business experience or a PhD, from an accredited institution, in a relevant scientific discipline.
Project management experience
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.
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.
Work experience in cGMP, European Union (EU) or APHIS regulated animal health industry required.
NOTE : Relevant BIVI experience may be weighted more significantly.
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, QA - APR - Specs
Location: Americas-US-MO-Saint Joseph
Requisition ID: 1812397