Senior Quality Systems Specialist
INCOG BioPharma Services, Fishers, IN, United States
The Specialist will be a primary partner on the following key areas:
Developing and supporting the INCOG approach to investigation processes.
Developing and supporting the INCOG approach to deviation trending and tracking.
Developing and supporting Change Control and CAPA review and evaluation board(s).
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 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
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
onconforming 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.
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.
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.
Additional Preferences
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 year’s experience as a Quality System administrator in an electronic Quality Management System.
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.
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.
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Developing and supporting the INCOG approach to investigation processes.
Developing and supporting the INCOG approach to deviation trending and tracking.
Developing and supporting Change Control and CAPA review and evaluation board(s).
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 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
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
onconforming 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.
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.
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.
Additional Preferences
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 year’s experience as a Quality System administrator in an electronic Quality Management System.
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.
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.
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