Compliance Specialist III
Core
Establishes and maintains quality systems for investigational new drugs, biologics, and medical devices to ensure regulatory and customer compliance.
Role type
Quality Assurance Specialist (Regulatory Compliance)
Builds
Quality systems, Standard Operating Procedures (SOPs), audit reports, and compliance documentation for pharmaceutical and medical device operations.
Domain
Life Sciences / Pharmaceutical / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SOP development and maintenance, regulatory auditing, vendor qualification management, change control and deviation handling, corrective and preventative action (CAPA) implementation, complaint investigation, ICH requirements knowledge, APQR generation and submission, supplier quality oversight, cross-functional project participation.
Preferred skills
None stated
Technologies
None stated
Responsibilities
Establishing current quality systems for investigational new drugs, biologics, and medical devices; performing routine maintenance and periodic reviews of SOPs to align with regulatory requirements; auditing departments for compliance and generating audit reports; providing quality oversight of vendor qualifications including questionnaires and quality agreements; maintaining Change Control, Deviation, Out of Specification, CAPA, and complaint investigation systems; ensuring facility compliance status and audit readiness; implementing quality compliance training; training new employees and junior team members on procedures and cGMP regulations; working independently on projects as a Quality Assurance Representative; ensuring proper generation, review, and submission of APQRs; partnering with Logistics and QA to oversee supplier management and site-specific supplier quality issues; participating in cross-functional teams for process control and continuous improvement projects.
Seniority
Mid-level, independent contributor
