Title Senior Specialist, Quality Assurance 1st Shift
Our Culture 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 patient’s 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 Roxane Inc., Roxane Laboratories Inc., Boehringer Ingelheim Chemicals, Boehringer Ingelheim Vetmedica Inc. and Ben Venue Laboratories Inc., is an equal opportunity employer. M/F/D/V
Description 1. Assembly and auditing of batch records to assure all regulatory
and internal requirements for the product quality. Create and maintain certificate templates, create certificates as needed for batch release and send to appropriate parties, as required. Perform product, component and raw material system movements to release or quarantine status in MRP, as applicable. Included is the verification of calculations associated with formulation, and overall review of documents for cGMP and EU compliance.
2. Perform sampling, inspecting and releasing of in-process materials such as antigen and cells, as required.
3. Perform routine review of batch records and view daily production to evaluate day to day compliance with SOPs and MD’s.
4. Perform and document assigned audits of the quality systems within the BI-Iowa manufacturing and quality control testing sites ensure compliance to internal written procedures, domestic and international regulations and quality standards, requirements and guidance documents.
5. Review and approve assigned new and revised specifications, procedures, processes, and methods, associated with pharmaceutical production operations.
6. Assist in assigned investigations (e.g. audits, product complaints, discrepancies, CAPA and production) and propose appropriate corrective and preventive actions for associated issued and events relating or pharmaceutical production operations and associated quality systems. Assist with the timely completion of investigations and the implementation and completion of corrective and preventive actions.
7. 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
8. Other duties as assigned by the Manager, Team Leader or Group Leader.
Requirements BS degree in science or a related discipline with 8 years of relevant work experience in a pharmaceutical or biological related industry, or AA degree in a science or related field plus 10 years relevant work experience, or 12 years of relevant work experience in a pharmaceutical or biological regulated industry.
Thorough understanding of cGMP’s, and domestic and foreign regulatory and compliance requirements, with a strong ability to understand and interpret regulations.
Strong theoretical and practical knowledge of regulated processes, production of pharmaceutical/biological regulated articles.
Demonstrated ability to work in a team environment.
Exceptional logical skills with excellence in writing and verbal communication and a strong attention to detail.
Excellence in comprehension and application of cGMP regulatory requirements for the production and distribution of regulated pharmaceutical/biological articles.
Req ID VM0512110
Date Posted 5/14/2010
Location IA, Fort Dodge