American Society for Quality - Kansas City ASQ Section 1301

Department	QA/QC
Job Type	Full Time
Job Category	Other
Location	Missouri-Kansas City/Independence
City	St. Joseph
Our Culture	In a world where business is driven by short term financial goals, Boehringer Ingelheim is truly a company with a different philosophy. Although we are one of the largest and fastest growing pharmaceutical companies in the world, we have been able to maintain a dedication to our values. Our focus is on helping patients, serving our customers and improving the quality of life for the millions of people who rely on us. Simply put, we have remained committed to doing the right thing-for our customers, our communities, our employees and everyone we serve. At Boehringer Ingelheim, we realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to create a healthy working environment-meaningful work, diversity, mobility, networking and work-life balance Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, as well as our partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background checks and drug screenings.
Job Description	QUALIFICATIONS: A BS/BA degree (preferably in Science/microbiology etc.) with 5-7 years of QA experience in regulated pharmaceutical/vaccine manufacturing environment or related field is required in order to understand technical specifications and for comprehension and application of USDA and EU regulatory requirements for the production and distribution of regulated biological articles. This individual must have the ability to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment, and recommend improvements to better compliance levels A strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology, etc. is essential for performing the release job functions DUTIES & RESPONSIBILITIES: Assembly and review of all production batch records including blending, sterile filling, environmental monitoring, critical systems and sampling records for accuracy and conformance to USDA/EU specifications Review, approval and submission of APHIS form 2008s for release permission of each serial Review, approval and submission of documentation required for EU release (Master Batch Protocols, Certificates of Analysis, Declarations of Compliance) Audit QC technical data and assists with resolution of non-conforming lots Physical release of materials The incumbent will assist with internal and external audits, and support the technical groups as required in other QA functions
Requisition ID	VM0110008
Date Posted	03-Jun-2008