Quality Assurance Specialist Clinical Jobs

4-7 years of Quality Assurance experience required

Advanced computer skills a must

Excellent organization and documentation skills required

Responsibilities include, but are not limited to:

Evaluate, track, and monitor clinical operations activities and standards internally and client facing

Improve existing and develop new clinical regulatory quality standards and procedures

Gain valuable experience in healthcare delivery and payment reform research and development

Manage projects, communicate effectively, and provide excellent customer service

4-6 years of relevant experience

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Contribute to the improvement of healthcare quality and cost reduction in Medicare, Medicaid, and CHIP programs

Work with a team focused on shifting the healthcare system towards value-based care

Assist with clinical risk management

Coordinate with Quality Management about room/documentation audits to guide practitioner action plans

Coordinate with CMO, SVP, Network, Director of Clinical & Quality, and/or Manager of Quality to support execution of special clinical projects

2+ years of clinical experience

Voluntary benefits including disability, basic life or pet insurance, etc.

Flexible PTO and Remote First Environment

Excellent change management skills, with the ability to assess readiness and implement appropriate opportunities for change.

Develop and deliver training programs on quality assurance topics to enhance staff knowledge and compliance awareness.

Stay abreast of regulatory requirements, industry best practices, and emerging trends in clinical quality assurance.

Minimum of 3-5 years of experience in the pharmaceutical industry, with a strong understanding of GxP regulations and practices.

Proficiency in Good Clinical Practice (GCP) guidelines and experience with regulatory inspections (FDA, MHRA, EMA, etc.).

Demonstrates a customer-focused approach and possesses excellent interpersonal, communication, and facilitation skills.

Support the Clinical vendor qualification, selection, and management process

Working knowledge of inspection management

Demonstrated project management and leadership skills

Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries

Minimum of 2 years experience in clinical and/or quality system compliance and auditing

Knowledge of Good Clinical Practices (GCP) and all applicable regulations

Provide inspection management support as appropriate.

Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

Provides training and mentorship to less experienced members of QA staff.

BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.

GCP QA site audit experience.

Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.

Provide inspection management support as appropriate.

Design and actively participate in special assignments on various project teams and work streams as determined by QA management.

Provides training and mentorship to less experienced members of QA staff.

BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.

GCP QA site audit experience.

Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.

Equivalent combination of education and experience.

Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.

Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.

BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,

MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,

PhD in related discipline and a minimum of 5 years of related QA experience; or

Strong project management, communication skills, and customer service skills; and

Experience developing and interpreting detailed quality measurement technical specifications and evaluating measure testing, including measure validity and reliability.

Strong analytic and strategic planning skills;

4-6 years of relevant experience.

Deep understanding of operationalizing quality measures, including data collection using claims, clinical registries, and electronic health records;

Patient report outcome measures (PROMS)

Experience with project management tools, spreadsheets, tracking deliverables and issues, meeting deadlines

Patient Safety/Risk Management experience preferred

Monitors for appropriate utilization, implements the policy, and communicates with all external stakeholders including clients, and account managers

Excellent written and verbal communication, and presentation skills

Ability to manage multiple projects simultaneously

5 years’ experience as an RN required, with at least 3 years in a Healthcare Quality role preferred.

Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines

Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.

Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution

Perform additional GCP related activities upon request by CQA management

Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.

Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.

Support the Clinical vendor qualification, selection, and management process

Working knowledge of inspection management

Demonstrated project management and leadership skills

Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries

Minimum of 2 years experience in clinical and/or quality system compliance and auditing

Knowledge of Good Clinical Practices (GCP) and all applicable regulations

Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.

Experience leading audits of GCP vendors and investigator sites.

A strong team player with great interpersonal and written communication skills

Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions.

Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.

Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.

Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.

Solid knowledge of drug development, clinical trial management and/or GCP compliance processes

Education, Experience, Competencies And Skills

Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements

Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations

Ensure compliance with Sponsor Learning Curricula, corporate and/or GXP requirements.

Demonstrated knowledge and/or prior experience in Quality Assurance

Ability to manage multiple studies/projects and to collaborate effectively in a dynamic, cross-functional matrix environment

BS/BA with 8 to 10 years of experience in pharmaceutical / biotech industry with experience in the GLP/GCLP environment

Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GCLP

Practical knowledge of GLP/GCLP related audits activities and business standards

Prior experience with nonclinical studies and CRO oversight

Applies technical skill and abilities for program design, development, implementation and evaluation

Utilizes management expertise to assist communities with resident care and nursing personnel issues

Collaborates with the senior management team members to achieve and maintain company goals

Experience using Microsoft Office and Outlook software. Basic typing skills required

Able to communicate effectively with all levels of management, associates, residents, family members, state regulatory agencies, hospitals, and outside contacts

Responsible to maintain current knowledge of state and local regulations

Prepares for and hosts external sponsor / IRB audits

Investigates and responds to Corrective and Preventive Action (CAPA) requests in collaboration with Clinical Operations and CQA.

Works with Clinical Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.

Reviews monitor letters for issue escalation and quality performance issues

Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.

Coordinates and facilitates quality review meetings with appropriate CQA staff and operational leadership

Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs.

Minimum 5+ years’ experience in clinical stage pharmaceutical companies

Experience developing GCP processes for the best industry practices and training personnel

Participating in review and approval of clinical study documents and clinical SOPs / Guidance Documents

Managing study specific Clinical Study Audit Plans (CSAP) compliance for assigned program by using risk-based approach for the company’s clinical studies

Reviewing and approving investigational product (IP) temperature excursions to ensure release or rejection of IP in a timely manner

Generates reports as requested by management (i.e., accuracy, quality).

Intermediate computer skills (e.g. Microsoft Office, Outlook, Internet search) and experience with health care systems and documentation (EMR, billing and claims).

Strong analytical and problem-solving skills.

Demonstrated experience with writing, documentation, and editing.

One-time furniture and equipment allowance for employees working from home

Remote within WA, ID, OR, and UT

Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities;

Identify and implement balanced fit-for-purpose quality management; Develop and recommend strategies and tactics for success

Identify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigations to management

Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience required

5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations.

1+ years of GCP QA auditing experience