Quality Associate I — Quality Compliance
Core
Provide flexible support across Quality Systems, Compliance, Investigations, and related quality programs to maintain regulatory compliance and operational excellence.
Role type
Associate Quality Systems & Compliance Specialist
Builds
Quality records, documentation, investigation reports, audit evidence packages, and trend reports
Domain
Pharmaceutical/Medical Device Manufacturing Quality Assurance
Deliverable
dashboards & analysis
Required skills
Organizational skills, attention to detail, Microsoft Office proficiency, ability to manage multiple priorities, written and verbal communication
Preferred skills
Knowledge of cGMP regulations, experience with document control, familiarity with eQMS platforms like TrackWise, exposure to regulated manufacturing environments
Responsibilities
Maintain QMS records and assist with change controls, CAPAs, complaints, and audits; Enter and manage data in electronic quality systems; Gather documentation for investigations and audits; Track action items and training completions; Compile quality data for management reviews and trend reports; Support internal and regulatory audits by preparing evidence packages
Seniority
Entry-level (0-2 years experience)
