Quality Specialist

Duration & Type: 12 months Contract with a major pharmaceutical industry client Location: Indianapolis, Indiana. The position could be remote, with a need to travel to the site probably 5-10 days per month and the person would need to be in a surrounding state or greater mid-west area. Responsibilities: Assist in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation Assure compliance with SOPs upon implementation. Investigate and propose additional corrective actions as required. Communicate with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. Assist in ensuring validation approaches are current to regulatory expectations and standards within the industry: Write test cases to validate critical control points, user requirements, and functional designs. Execute test cases as needed. Interact with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. Assist in analyzing validation data to ensure acceptance criteria are met and in writing validation summaries. Prepare validation reports for distribution. Evaluate adequacy of corrective actions. Participate in the evaluation of processes, systems, and individual center equipment needs and final approval process Prepare validation equipment for use at the Donor Center and for evaluation upon return. Assist in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. Track and monitor process/system failures/events. Provide feedback to Donor Center management regarding requirements, results from data collected, and validation processes. Monitor customer complaints and nonconformance related to equipment failures. Required: Education: Bachelor’s degree Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem-solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. For consideration, please send resume to career@infoquestgroup.com