Associate, Compliance & QA – Technology
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Job Description
Compliance and QA associate supporting WCG’s clinical-trial technology organizations. Maintaining quality systems, validating regulated systems, and conducting internal and vendor audits.
Responsibilities:
- Assist and support maintenance of compliance standards and measures across WCG Technology Solutions organizations, including Infrastructure, Information Technology, Software Development and Engineering.
- Work alongside WCG Technical Solutions staff to achieve corporate and departmental compliance goals.
- Ensure compliance with WCG’s Quality Management System and technology processes.
- Engage in the continued development, maintenance, and enforcement of the WCG Quality Management System and quality department standards.
- Support maintenance of WCG quality goals, objectives, and process improvements.
- Educate WCG staff on quality department standards and best practices.
- Author and revise internal technology standards, including IT and Software Development Policies and SOPs.
- Support development, validation, implementation, and change management of systems in line with GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.
- Develop and review validation deliverables related to implementation or development of WCG systems.
- Support investigation of Quality Events, CAPA, deviations, and notes to file; execute assigned compliance tasks within defined timelines.
- Conduct internal audits and external vendor qualification audits.
- Support external audits through preparation, audit-report review, and finding resolution.
- Maintain current knowledge of quality legislation and regulatory compliance best practices.
- Perform other duties assigned by the supervisor.
Requirements:
- Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience to perform the job.
- Two (2) to four (4) years’ experience in a quality/regulatory compliance position supporting and contributing to quality assurance projects/assignments.
- Knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies.
- Experience in supporting customer/sponsor audits of organizational processes, training, documentation, etc.
- Knowledge of 21 CFR Part 11 scope and application and Computerized System Validation processes.
- Experience in the execution and documentation of Computerized System Validation efforts of systems used in Clinical Trials.
- Experience delivering training materials related to company standards and regulatory requirements.
- Ability to contribute to and execute workstreams within multi-departmental projects.
- Effective communication (written and oral), organization and interpersonal skills as well as the ability to interact with WCG staff, sponsors, and regulatory agencies as needed.
- Demonstrated technical writing skills.
- Ability to problem solve and engage in conflict resolutions.
- Ability to multitask and to work efficiently and independently.
- Travel requirement of 5%–10%.
Benefits:
- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
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