Manufacturing Investigation Report Writer
Wyeth (Central/Des Moines, Iowa)

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Job Description: Job Title: Manufacturing Investigation Report (MIR) Writer Department: Quality Assurance Location: Fort Dodge, IA At Fort Dodge Animal Health, a division of Wyeth, we are dedicated to our vision of leading the way to a healthier world for animals. Recognized for our breakthroughs in veterinary medicine and innovative product development, our reputation in the animal-care industry precedes us. More than 3,500 employees keep our reputation strong by bringing us a full range of talent. Wyeth, a Fortune 500 Company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that it is our employees who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop, and motivate individuals whose skills, values, and work ethic will grow and improve our business. JOB SUMMARY The position of Manufacturing Investigation Report Writer will involve investigation of the root cause of failure to meet specifications in Pharmaceutical Manufacturing. The incumbent must try to prevent reoccurrence of these events by identifying the root cause of the problem and recommending and tracking corrective actions. Investigators should consider the impact of deviations on the process and product. As part of the Quality System, the Investigators initiate Manufacturing Investigation Reports (MIRs) and coordinate the actions required for their resolution, including CAPA activities. Investigations are required to be completed and approved by subject matter experts and QA Management within predetermined timelines and according to Regulatory, Corporate and Divisional guidelines. BASIC QUALIFICATIONS B.S. in life sciences and at least 4 years of experience in Pharmaceutical/Biological Manufacturing Operations or Quality Assurance Excellent problem solving skills, analytical ability and rational thought process. Clear verbal and written communications coupled with computer literacy. ADDITIONAL QUALIFICATIONS Practical and theoretical knowledge of compliance guidelines of the FDA, USDA, VMD, MHRA, EMEA and other applicable Regulatory Agencies. Ability to draw conclusions from information found in databases. Ability to interpret and document information using standard Quality systems. Must be able to ascertain the correctness of batch records. Knowledge of computer systems and database structure, including Microsoft Office, Powerpoint and Excel is necessary. Must be well versed in GMP documentation requirements. Ability to write clear and concise summaries of investigations. Must be able to follow events chronologically and assess their impact. The investigator has to confirm that all the key elements of the investigation process have been covered. It is a requirement to possess good investigative writing skills. The incumbent will work under limited supervision on routine activities. Individual must possess the ability to review workload and determine the most efficient and effective way to conduct the investigations, taking into account criticality of events and market needs. CAPA commitments will need to be tracked to make sure corrective actions are effective and valid over time. The incumbent must have the ability to conduct thorough, unbiased investigations and root cause analysis, analyze information, spot trends, and identify appropriate corrective and preventative actions. The incumbent will have an inquisitive mind and pursue facts in a disciplined manner, using the tools and expertise available. Since most investigations must be concluded within a specified timeline, a sense of urgency should be demonstrated. The incumbent must possess an ability to work with a team of immediate group members and to work cross functionally as necessary. Positive relationships must be built and sustained. The incumbent must listen and check prior to acting. Commitments and promises must be honored. The incumbent must have the ability to share technical expertise with less experienced colleagues to solve problems, and may be asked to train others on SOP’s TrackWise and MIR writing. The incumbent must ensure that the company products meet defined quality standards. The incumbent must possess the ability to assist in writing documents and procedures. Fort Dodge Animal Health, a division of Wyeth, offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs. For more information, visit our website at http://www.wyeth.com. Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth, including all of its divisions, is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet, or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void. Search firms are essential to the recruitment and staffing efforts at Wyeth, and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.

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