Quality Assurance Specialist Clinical Jobs

Skagit Regional Health - Main Campus

Nursing degree required. BSN preferred.

Current Washington State RN License required. CPHQ preferred.

Advanced knowledge of Microsoft Word, Microsoft Excel, and PowerPoint.

5-8 years of Pharmaceutical Clinical Research and Trial experience.

Previous Pharmaceutical Clinical Research and Trial audit and/or monitoring experience is required.

Strong communication skills (verbal & written).

Prior Pharmaceutical and medical device industry experience.

Reviewing, revising, organizing, planning, summarizing, editing, and proofreading Clinical and Clinical Quality procedures, work instructions, forms, and templates.

Demonstrated project management skills, prioritisation and management of cross-functional activities

Provide support in the co-ordination and management of Regulatory Inspection activities for applicable clinical programmes.

Extensive knowledge of global, regional and national GCP regulatory requirements and regulations

Implement and manage Quality Assurance Plans for all programmes where audit activities are performed.

A broad scientific/pharmaceutical industry background with relevant experience in pharmaceutical research and/or pharmacovigilance.

Previous experience of Good Clinical Practice and/or Clinical Quality Assurance

Using clinical knowledge, experience, and problem solving skills to interpret clinical quality data, identify opportunities for improvement, and generate ideas.

At least three years of experience as a registered nurse, preferably in primary care, care management, or outpatient clinics

Prior experience in a quality improvement role or a relevant certification is a plus

Reviewing dashboards of quality metrics, identifying potential issues, and alerting appropriate managers.

Be able to identify and communicate factors that contribute to a good patient experience and outcome.

Reviewing documentation for accuracy, clinical judgment, and adherence to protocols and workflows.

Tuition and continuing education reimbursement

Full suite of voluntary benefits such as identity theft protection and pet insurance

Full medical, dental and vision coverage

Retirement plans to include pension plan and 403(b) matching

Paid time off. Start your employment at UCHealth with PTO in your bank

Employer-paid life and disability insurance with additional buy-up coverage options

Education, Experience & Skills Requirements

Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement

Attention to detail and proper use of tools for information processing and electronic quality management systems

Bachelor's degree in a scientific discipline or equivalent experience

Minimum of 5 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred

Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)

Experience with Electronic Documentation Management System (EDMS) and Electronic Master File system (eTMF);

Participate in continuously improving and maintaining our quality management system and assist with compliance activities;

Participate in vendor qualification audits as assigned. Including production of audit plans, reports, collection of responses, and follow-up;

2+ years of Good Clinical Practices (GCP) related experience required; auditing experience is preferred;

Certification as a Quality Auditor or related certificate is a plus;

Exceptional technical writing, review, and analytical abilities;

5 years of Line Management Experience

Senior Management experience in Quality Assurance.

Required Knowledge, Skills and Abilities:

Provide actionable insights to customer counterparts, QA Leadership and Senior Management

Conduct trend analysis of audit results and provide QA management with initial root cause analysis

May present trend analysis results and QA metrics and insights to IQVIA Senior management

Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations

Minimum 7 years of GCP/GLP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device)

Experience in supporting Regulatory Authority GCP inspections

Experience managing internal and contract personnel and external vendors and auditors

Participate on cross-functional teams as SME in GCP/GLP/GCLP to provide guidance and risk-based options that promote compliance.

Identify quality process and system improvements and implement timely actions.