Tech Compliance QA Associate — Quality & Regulatory Focus

FlagshipKansas; Topeka, Northern (KS, KY); Hybrid; USD 52,000 - 82,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

401(k) with company match

Flexible spending accounts

Employee assistance program

Tuition reimbursement

On-the-job training

Certification assistance

Continuing education

Job summary

WCG Clinical in Topeka, Kansas seeks an Associate in Compliance & QA (Technology) to support maintenance of quality standards across technology solutions, ensuring regulatory compliance and alignment with QMS. You will work with staff to meet GxP, 21 CFR Part 11, GDPR, and HIPAA requirements.

Responsibilities include audits, validation deliverables, training, and collaboration across departments to uphold high-quality processes and documentation.

Qualifications

• Two to four years’ experience in a quality/regulatory compliance role.
• Knowledge of FDA and ICH guidelines as they apply to clinical studies.
• Experience supporting audits of processes, training, and documentation.
• Knowledge of 21 CFR Part 11/Computerized System Validation.
• Strong technical writing and communication skills.

Responsibilities

• Develop and maintain the Quality Management System.
• Support quality goals and process improvements.
• Educate staff on quality standards and best practices.
• Assist with IT/Software Development policy documents.
• Support validation deliverables and regulatory compliance activities.
• Participate in internal and external audits.
• Maintain knowledge of quality legislation and best practices.

Skills

Quality assurance

Regulatory compliance

FDA & ICH knowledge

GCP knowledge

Audit support

Documentation

Computerized System Validation

Communication skills

Education

Bachelor's degree in a scientific or technical field

Job description

WCG Clinical in Topeka, Kansas seeks an Associate in Compliance & QA (Technology) to support maintenance of quality standards across technology solutions, ensuring regulatory compliance and alignment with QMS. You will work with staff to meet GxP, 21 CFR Part 11, GDPR, and HIPAA requirements.

Responsibilities include audits, validation deliverables, training, and collaboration across departments to uphold high-quality processes and documentation.