Associate, Compliance & QA (Technology)

About the role

The Associate, Compliance & QA (Technology) supports and contributes to quality assurance projects/assignments, maintaining compliance standards and processes across WCG Technology Solutions organizations. This role also involves supporting external audits and investigations of Quality Events/Corrective Actions Preventative Actions (CAPA).

Responsibilities

• Engages in the development, maintenance, and enforcement of the WCG Quality Management System and quality department standards.
• Supports efforts regarding the maintenance of WCG quality goals, objectives, and process improvements.
• Edits and revises internal technology standards, including IT and Software Development Policies, SOPs, etc.
• Supports the development, validation, implementation, and change management of systems to ensure compliance with regulatory agency regulations and guidance, including GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.
• Executes assigned compliance tasks in adherence of defined timelines.
• Conducts internal and external vendor qualification audits to ensure compliance with applicable WCG process, regulatory agency regulation, and guidance.
• Maintains current knowledge with respect to quality legislation and regulatory compliance best practice.
• Supports external audits including audit preparation activities, review of audit reports, and executing finding resolutions.

Requirements

• Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience.
• 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) skills, 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.

Qualifications

• Education Requirements: Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience.
• Certifications/License/Registration Requirements: None

Pay

The expected base salary range for this position is $52,470-$81,500. This salary range may vary based on the candidate’s qualifications, experience, skills, education, and geographic location.

Schedule

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