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