Quality Systems Specialist - INCOG BioPharma Services : Job Details

Description The Specialist will be a primary partner on:

• Developing and supporting the INCOG approach to investigation processes.
• Developing and supporting the INCOG approach to deviation trending and tracking.
• Participating in the Change Control and CAPA review and evaluation board(s).
• Generating Quality Management System metrics, dashboards, and reporting.

Working closely with the Senior Manager of Quality Assurance and other Quality Systems Specialists, the Specialist will be instrumental in engaging the site in performing investigations, change plan development and change action and CAPA fulfillment, and leading the assessments for risk against validated systems and process states, and impact to product quality and safety. The Specialist will work directly with Project Management in acting as Quality liaison with Client Quality Units. They will coordinate site SMEs in Client engagement to ensure Quality Event timelines are met in the furtherance of product quality and release assurances. The Specialist will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Specialist will have strong familiarity with industry standard Deviation/investigation, root cause assessment, risk assessment, change management, and CAPA processes. The Specialist will have familiarity with electronic Quality Management System(s) and Microsoft Office suite products, and the development of process metrics. They will thrive in a team environment, but will also work autonomously utilizing strong self-management and organizational skills. The Specialist will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes. Essential Job Functions:

• Perform robust investigations to determine root causes for deviating conditions or nonconforming materials or products across technical departments, in alignment with Subject Matter Experts in those areas.
• Support internal customers on the design and documentation of sitewide change controls, deviations and CAPAs and provide assessment of their impacts and risks.
• Support internal customers with, and provide troubleshooting for, the electronic Quality Management System.
• Maintain metrics for the Quality Management processes in support of assessing process health and trends to determine needs for process improvements or deviation/nonconforming product prevention.
• Lead discussions with auditors and inspectors on the planning, enacting, assessments, and results of completed or in-process Quality Events.
• Provide planning and assessment support in Deviation/investigation, Change Control, or CAPA authoring and review decision-making.
• Provide notification, support, and reporting out of Quality Event details and timelines to Clients, and coordination with internal SMEs toward timeline requirements.

Special Job Requirements:

• Bachelor's degree in a scientific field
• Minimum of 5 years' experience in a regulated industry.
• Minimum of 3 years' experience performance and management of Quality Systems processes.
• Minimum of 3 years' experience with internal customer service in support of Deviations, Change Controls and/or CAPAs.
• Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
• Able to lift and move boxes of up to 50 lbs and stand for moderate periods of time.

Additional Preferences:

• 3 years' experience as a user in an electronic Quality Management Systems.
• 1 years' experience as a Quality System administrator in an electronic Quality Management Systems.
• 2 years' experience with external customer service, support/troubleshooting and/or presenting publicly.
• Experience and comfort with direct contact with industry regulators in audit/inspection conditions.
• Certification in Risk Assessment, Root Cause Analysis, and/or Investigation Management.
• Microsoft Office Specialist or Expert certification in Word and/or Excel.
• Moderate to expert level experience with Microsoft PowerPoint, Visio, and/or other presentation software packages.

Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.