Associate, Compliance & QA – Technology

This is a fully remote position, open to applicants in United States.

📋 Description

• Participates in the ongoing development, upkeep, and enforcement of the WCG Quality Management System along with quality department standards.

• Aids in the maintenance of WCG's quality objectives, goals, and process enhancements.

• Provides education to WCG staff regarding standards and best practices of the quality department.

• Collaborates with WCG personnel to create and update internal technology standards (e.g., IT and/or Software Development Policies, SOPs, etc.).

• Assists in the development, validation, implementation, and change management of systems to ensure compliance with regulatory agency requirements and guidance, including but not limited to GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.

• Aids in the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF), while executing assigned compliance tasks within specified timelines.

• Performs internal audits to verify that internal standards and staff performance comply with applicable WCG processes, regulatory agency regulations, and guidance.

• Conducts external vendor qualification audits to ensure vendor standards and performance align with applicable WCG processes, regulatory agency regulations, and guidance.

• Supports external audits by preparing for audit activities, reviewing audit reports, and resolving findings.

• Keeps up-to-date with current quality legislation and best practices in regulatory compliance.

• Performs other duties as assigned by the supervisor, which may occasionally be unrelated to the described position.

⛳️ Requirements

• Bachelor’s degree in a scientific, technical, or related field, or an equivalent combination of education, skills, and experience necessary for the role.

• Two (2) to four (4) years of experience in a quality/regulatory compliance role, contributing to quality assurance projects and assignments.

• Familiarity with current regulatory (FDA & ICH) & GCP guidelines applicable to clinical studies.

• Experience supporting audits of organizational processes, training, documentation, etc., by customers/sponsors.

• Understanding of the scope and application of 21 CFR Part 11 and Computerized System Validation processes.

• Experience in carrying out and documenting Computerized System Validation efforts for systems used in Clinical Trials.

• Proven experience in creating training materials related to company standards and regulatory requirements.

• Ability to contribute to and execute workstreams within multi-departmental projects.

• Strong communication skills (both written and oral), along with organizational and interpersonal abilities, enabling interaction with WCG staff, sponsors, and regulatory agencies as required.

• Demonstrated proficiency in technical writing.

• Capable of problem-solving and engaging in conflict resolution.

• Ability to multitask and work efficiently and independently.

🏝️ Benefits

• Comprehensive benefits package including Health, Dental, Vision, Life Disability, 401k with matching, and flexible spending accounts.

• Employee Assistance Programs and additional resources for work/life balance.

• Referral bonuses and tuition reimbursement.

• Flexible Paid Time Off (PTO).

• Volunteer Time Off to support community initiatives.

• Opportunities for career growth through on-the-job training, certification assistance, and continuing education reimbursement.