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INCOG BioPharma Services is seeking a Quality professional to be a cross-functional agent for Quality Assurance across the Quality Systems process domains. The Quality Systems Specialist will be responsible for support of the Change Control, Deviation, and CAPA processes and a partner for the functional departments in their navigation and routing of events thereof. The Specialist will also provide support to the Sr. Manager of Quality Assurance in the administration of the electronic Quality Management System, as applicable to the Quality Events modules.
The Specialist will be a primary partner on:
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.
Key Responsibilities:
Technical Leadership
Customer Support
Minimum Qualifications
Preferred Qualifications
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.
Full Time
Building Construction
$75k-92k (estimate)
05/18/2023
07/11/2024
INDIANAPOLIS, IN
<25
2021
<$5M
Building Construction
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