Associate, Compliance & QA – Technology

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

📋 Description

• Provide assistance and support in upholding compliance standards and measures throughout WCG Technology Solutions, which encompasses Infrastructure, Information Technology, Software Development, and Engineering.

• Collaborate with WCG Technical Solutions personnel to meet corporate and departmental compliance objectives.

• Ensure adherence to WCG’s Quality Management System and associated technology processes.

• Participate in the ongoing development, maintenance, and enforcement of the WCG Quality Management System and the quality department's standards.

• Aid in the maintenance of WCG quality goals, objectives, and process enhancements.

• Educate WCG employees on the standards and best practices of the quality department.

• Write and update internal technology standards, including IT and Software Development Policies and Standard Operating Procedures (SOPs).

• Assist in the development, validation, implementation, and change management of systems in compliance with GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.

• Create and assess validation deliverables pertaining to the implementation or development of WCG systems.

• Support the investigation of Quality Events, CAPA, deviations, and notes to file; complete assigned compliance tasks within specified timelines.

• Conduct internal audits and external vendor qualification audits.

• Facilitate external audits by preparing documentation, reviewing audit reports, and resolving any findings.

• Stay updated on quality legislation and best practices for regulatory compliance.

• Carry out other tasks as assigned by the supervisor.

⛳️ Requirements

• Bachelor's degree in a scientific, technical, or related area, or an equivalent combination of education, skills, and experience suitable for the role.

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

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

• Experience in assisting with customer/sponsor audits regarding organizational processes, training, documentation, etc.

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

• Experience in executing and documenting Computerized System Validation efforts for systems utilized in Clinical Trials.

• Experience in delivering training materials related to company standards and regulatory requirements.

• Capability to contribute to and implement workflows within multi-departmental projects.

• Strong communication (both written and oral), organizational, and interpersonal skills, along with the ability to interact effectively with WCG staff, sponsors, and regulatory agencies as required.

• Proven technical writing abilities.

• Problem-solving skills and the ability to engage in conflict resolution.

• Capacity to multitask and work effectively and independently.

• Willingness to travel 5%–10% of the time.

🏝️ Benefits

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

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

• Referral bonuses and tuition reimbursement opportunities.

• Flexible paid time off (PTO).

• Volunteer time off to support community initiatives.

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