Senior Quality Systems Specialist

INCOG BioPharma Services • Fishers, IN

1d • Onsite

About The Position

The Specialist will be a primary partner in developing and supporting INCOG's approach to investigation processes, deviation trending and tracking, and Change Control and CAPA review and evaluation board(s). This role also involves generating Quality Management System metrics, dashboards, and reporting. Working closely with the Quality Systems Team and cross-functional departments, the Specialist will be instrumental in engaging the site in performing Deviation Triage, change plan development, change actions, and CAPA creation. The Specialist is expected to demonstrate excellent interpersonal skills, develop productive customer-centric working relationships with internal and external customers, and maintain high visibility across all departments. Excellent written and oral communication skills are essential for clearly and concisely articulating complex issues to diverse audiences. The role requires strong familiarity with industry-standard Deviation/investigation, root cause assessment, risk assessment, change management, and CAPA processes, as well as electronic Quality Management System(s) and Microsoft Office suite products, and the development of process metrics. The ideal candidate will thrive in a team environment while also working autonomously, utilizing strong self-management and organizational skills. The Specialist will value the processes owned by internal customers and subject matter experts, possessing a demonstrated ability to support and influence positive outcomes in applying that knowledge to wider processes. At INCOG BioPharma, the company has built a world-class CDMO for parenteral injectable drugs, with a culture and priorities focused on building long-term value for customers, a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. The company seeks individuals who are eager to create systems from scratch and believe they can contribute insights for a better way of doing business that benefits customers by ensuring quality outcomes and accelerating their route to market.

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.
• Working knowledge of applicable FDA regulations (21 CFR Parts 210/211) and ICH quality guidelines (Q9, Q10) as they apply to Quality Systems processes in a GMP-regulated manufacturing environment.
• Demonstrated understanding of data integrity principles (ALCOA+) and their application in GMP documentation and electronic systems.

Nice To Haves

• Experience in a sterile/aseptic or parenteral injectable manufacturing environment, with familiarity with the complexity of Quality Events specific to this product type (e.g., environmental monitoring deviations, aseptic process deviations, media fills).
• 3 years’ experience as a user in an electronic Quality Management System; experience with Veeva Vault QMS or equivalent platform strongly preferred.
• 1 years’ experience as a Quality System administrator in an electronic Quality Management Systems.
• Experience and comfort with direct contact with industry regulators in audit/inspection conditions.
• Certification in Risk Assessment, Root Cause Analysis, and/or Investigation Management.
• ASQ certification (CQA, CQE, or CQIA) or equivalent industry-recognized quality credential.
• Experience with data visualization and metrics reporting tools such as Power BI, Tableau, Minitab, or JMP.

Responsibilities

• 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.
• Continuously improve and develop the Deviation Management program, Change Management program, and CAPA Management program and processes.
• 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.
• Assist in 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.
• Author, review, and revise controlled documents including SOPs, work instructions, and forms in alignment with document control procedures and GMP requirements.
• Support the preparation and compilation of Annual Product Reviews (APR) / Product Quality Reviews (PQR), including trending of Quality Events and process performance data.
• Champion data integrity principles (ALCOA+) across all quality systems documentation and support site training on data integrity expectations.

What This Job Offers

• Career Level: Senior
• Number of Employees: 101-250 employees