Specialist I, Quality Assurance Documentation - 3rd shift M-F

Job Department: QA/QCJob Category: Manufacturing and ProductionJob Description:
Boehringer Ingelheim is a family-owned company that is in the business of providing our customers with pharmaceutical and animal health products that significantly enhance their health and improve their quality of life. Our most important resource is our committed, creative and determined employees whose energy is focused on discovery, development and delivery of our innovative products to those who need them. The employees of Boehringer Ingelheim are our most important competitive advantage. Our global presence and thinking provides the opportunity for employees to work internationally and on teams, offering them visibility and the ability to influence the direction and outcome of critical projects. Competitive benefit and compensation programs reflect the Company’s high regard for its employees and enhance each person’s ability to balance the demands of work and personal responsibilities. Every employee at Boehringer Ingelheim contributes to the company’s uncompromising commitment to quality in our products, excellence in our scientific pursuits and high ethical standards of behavior. The diversity of our employees makes it possible for us to craft unique solutions to today’s complex business challenges. We are an equal opportunity employer. M/F/D/V.Internal Applicants must apply within the posting period: July 24 - July 28, 2006. Position is 3rd shift M-F.Duties and Responsibilities:
Perform batch record review/audit and final disposition of drug products in compliance with corporate policies and procedures and cGMP’s. Ensure all customer commitments are met including release date deadlines. Must be able to use sound judgment to assimilate product knowledge, procedures, cGMP's and past experience in making appropriate product "go"/"no go" decisions related to batch release.Clearly communicates basic quality review/audit of batch documentation procedures and issues to peers, customers and supervision.Responsible for the collection of Quality metric data. Evaluate trends and partner with Operations to develop appropriate solutions.Perform SAP and other transactions for each production batch as required.All other duties as assigned.Boehringer Ingelheim Roxane, Inc. and Roxane Laboratories, Inc are subsidiaries of Boehringer-Ingelheim Corp.INTERESTED EMPLOYEES SHOULD COMPLETE AN INTERNAL ONLINE APPLICATION FORM
REQUIREMENTS
Requirements:Four (4) year Baccalaureate Degree in a Scientific, Engineering and/or Quality field.Minimum of 3 years experience in a regulated industry (e.g. FDA, ISO).Demonstrated proficiency in interpersonal communication skills - both oral and written within various levels of the organization and outside companies.Excellent computer skills with specific work experience using Microsoft applications (Word, Excel) and SAP is a preferred.Ability to work independently with minimal supervision.Demonstrated problem analysis and problem solving abilities requiring attention to detail, accuracy, cGMP and scientific judgment.