Quality Assurance Associate

An individual in this role verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GCP and/or GLP) by performing study protocol, data, report, in-lab phase inspections where applicable, for all study types within a laboratory.  A QA Associate will lead in QA archive maintenance and record keeping, participate in internal and external facility and supplemental inspections, lead process improvement and harmonization efforts that promote best practices, initiate and review SOPs and prepare and deliver training in basic quality/regulatory matters.  At this level the individual will be starting to gain experience in assisting with client inspection hosting, and general QMS auditing.

• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
• QA statement preparation/review (internal/external) and report finalization
• Participates in internal and external facility and supplemental inspections
• Performs protocol, data, report, and in-lab phase inspections for all study types within a single laboratory to verify conformance to applicable SOP and regulatory requirements
• Prepares and delivers basic quality/regulatory training
• Mange all Clinical employee personnel files
• Assist in the development of training and competency of all clinical employees.
• Leads process improvement and harmonization efforts that promote best practices
• Coordinates the efforts for maintaining an effective quality system
• Manages, maintains and improves the QA system to meet the regulatory standards
• Oversees the review, update and maintenance of all SOP’s and other QA documents
• Performs regular facility audits to ensure compliance to our quality system, pertinent regulations, and governing regulatory body requirements
• Communicates any critical compliance risks to senior management
• Assisting with the preparation, coordination, and management of regulatory agency inspections
• Lead/support investigator site, vendor, and internal process audits per Ionis procedures and applicable regulatory requirements.
• Support the implementation of the Vendor Oversight Program for Development non-clinical and clinical programs/studies with the focus on quality and compliance perspectives
• Monitor Vendor Quality Agreements and update Approved Vendor Lists
• Assist in preparation and/or management of regulatory agency inspections and in enhancing inspection readiness program
• Assist in the review and/or approval of GLP/GCP and systems related SOPs to assess their adherence to applicable regulatory standards
• Maintains working knowledge of FDA, EU and other global regulations and guidance governing Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Privacy Requirements
• Executes other duties as delegated

Education, Experience, other Requirements and Qualifications:

• BA/BS, preferably in a scientific discipline or life sciences.
• 1-2 years of industry experience
• Experience as a quality auditor in a GxP-regulated environment or experience in a GLP regulated CRO (Preferred)