Makayla Smart
@makaylasmart
I’m a Senior Quality Assurance professional driving GMP deviations to actionable CAPAs, continuous improvement, and audit-ready compliance.
United StatesWhat I'm looking for
I’m a Senior Quality Assurance professional focused on turning GMP-related events into clear, accurate deviation reporting, root cause analysis, and effective corrective and preventative actions. At Novo Nordisk, I author comprehensive deviation reports, evaluate product and process risks, and ensure outcomes prevent recurrence.
In my Catalent experience (acquired by Novo Nordisk in December 2024), I facilitated and performed external client audits, partnering with Client Auditors and Catalent SMEs to present procedures, identify gaps in the Quality System, and maintain audit readiness. I’ve prepared backroom materials, scheduled audits, reviewed Project Plans and Quality Agreements, and assembled audit response reports for client approval.
I also support audit and compliance execution by reviewing and approving SME audit responses for accuracy, completeness, and regulatory alignment. I evaluate and approve CAPAs to confirm they’re actionable, tied to the response, and designed to close the identified gap.
Earlier, I led daily triage meetings with leadership to determine deviation leveling and followed through by opening TrackWise investigations and approving TrackWise deviations and CAPAs. I provided quality oversight in aseptic environments, reviewed in-process batch records for compliance, and supported quality documentation through EDMS change requests to site SOPs.
Experience
Work history, roles, and key accomplishments
Authored comprehensive deviation reports for GMP-related events, ensuring accurate root-cause analysis and evaluation of product and process risks. Partnered with cross-functional teams to define and implement corrective and preventative actions (CAPAs) to prevent recurrence and drive continuous improvement.
Senior Quality Assurance Representative
Oct 2023 - Present (2 years 8 months)
Facilitated and performed external client audits in multiple roles by presenting procedures with Catalent SMEs and identifying gaps in the quality system. Reviewed and approved audit responses and CAPAs for accuracy, completeness, and alignment with regulatory requirements, Catalent policies, and procedures.
Facilitated and performed external client audits by reviewing procedures and processes with client auditors and Catalent SMEs to identify quality system gaps. Completed client paper audits by reviewing applicable policies and procedures, requesting SME clarifications, and meeting audit deadlines.
Led daily triage meetings with leadership to determine deviation leveling and follow up in TrackWise. Opened TrackWise investigations for production-block deviations, reviewed and approved deviations and CAPAs, and provided quality oversight in aseptic and manufacturing environments.
Family Case Manager
Indiana Department of Child Services
May 2018 - Oct 2020 (2 years 5 months)
Investigated reports of child abuse or neglect and determined whether allegations were substantiated for the Indiana Department of Child Services. Conducted interviews, compiled evidence into written narratives, authored legal reports, and testified in court hearings regarding investigation findings.
Education
Degrees, certifications, and relevant coursework
Ball State University
Bachelor of Arts, English
Earned a Bachelor of Arts in English with minors in Creative Writing and Literature.
Western Governors University
Master of Science, Leadership and Management
Earned a Master of Science in Leadership and Management.
Availability
Location
United StatesAuthorized to work in
Job categories
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