Associate, Compliance & QA (Technology)

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

at WCG Clinical in Topeka, Kansas, United States

Job Description

About WCG

WCG delivers transformational solutions that accelerate clinical research and advance human health. We serve the experts, innovators, and pathfinders on the frontlines of science and medicine-empowering them to develop breakthrough therapies while ensuring the risks of progress never outweigh the value of human life. Together, we stimulate growth, maximize efficiency, and shape the future of clinical trials.

Why WCG

At WCG , we invest in our people because you are the driving force behind our mission. When you grow, our impact grows. When you thrive, research accelerates. We empower you to build a meaningful career while advancing the work that improves lives.

What we offer:

• + Comprehensive health and financial protection – Medical, dental, vision, life and disability insurance, 401(k) with company match, and flexible spending accounts
• + Resources that support your whole life – Employee assistance programs and work/life balance tools
• + Investment in your growth – Referral bonuses, tuition reimbursement, on-the-job training, certification assistance, and continuing education support
• + Time to recharge – Paid holidays, vacation, and sick time

We practice transparency in everything we do, including compensation. The salary range for this position reflects our commitment to fair, competitive pay based on your qualifications, experience, skills, education, and location. Together, we’ll find the right fit for your expertise and our shared mission.

Job Summary

The Associate, Compliance & QA (Technology) is responsible for assisting and supporting the maintenance of compliance standards and measures across WCG Technology Solutions organizations (Infrastructure, Information Technology, Software Development and Engineering, etc.) and ensuring such standards comply with regulatory requirements and best practice. This position is responsible for working alongside WCG Technical Solutions staff to achieve corporate and departmental compliance goals and ensure compliance with WCG’s Quality Management System and technology processes.

ESSENTIAL DUTIES / RESPONSIBILITIES

• + Engages in the continued 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.
• + Educates WCG staff on WCG quality department standards and best practices.
• + Engages with WCG staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al).
• + Supports the development, validation, implementation, and change management of systems to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, GDPR , and HIPAA . This would include the development and review of Validation deliverables related to the implementation, and/or development, of WCG systems.
• + Supports the investigation of Quality Events/Corrective Actions Preventative Actions ( CAPA ), deviations, and notes to file ( NTF ). Executes assigned compliance tasks in adherence of defined timelines.
• + Conducts internal audits to ensure internal standards and staff performance are compliant with applicable WCG process, regulatory agency regulation, and guidance.
• + Conducts external vendor qualification audits to ensure that vendor standards and performance are compliant with applicable WCG process, regulatory agency regulation, and guidance.
• + Supports external audits including audit preparation activities, review of audit report, and executing finding resolution.
• + Maintains current knowledge with respect to quality legislation and regulatory compliance best practice.
• + Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

EDUCATION REQUIREMENTS

• + Bachelor’s degree in a scientific, technical or related field, or equivalent combination of education, skills, and experience to perform the job.

CERTIFICATIONS / LICENSE / REGISTRATION REQUIREMENTS

• + None

QUALIFICATIONS / 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.

SUPERVISORY RESPONSIBILITIES

None

TRAVEL REQUIREMENTS

• ? 0% – 5%
• ? 5% – 10%
• ? 10% – 20%
• ? 20% – 50%
• ? >50%

Pay Range

USD $52,470.00 – USD $81,500.00 /Yr.

EEOC Statement

WCG is proud to be an equal opportunity employer. Qualified applicants will receive consideration for employment based on merit and without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender expression, gender identity, age, marital status, pregnancy, family or parental status, disability, genetic information, citizenship, veteran status, or any other legally recognized basis or status protected by federal, state, or local law. WCG complies with the Vietnam Era Veterans’ Readjustment Act and Section 503 of the Rehabilitation Act. We promote a “One WCG ” culture where all are welcome, respected, valued, and empowered to make a difference every day to advance clinical research.