WIRB-Copernicus Group

ABOUT WCG: WCG’s clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to develop new products and therapies to improve the quality of human health. It is our role to empower them to accelerate advancement, while ensuring the risks of progress never outweigh the value of human life.

WHY WE LOVE WCG: At WCG, our employees are our most valuable asset, and as with all our assets, we invest in them with an eye toward future success. We provide each eligible employee with a comprehensive set of benefits designed to protect their personal and financial health to help make the most of their future.

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
• Employee Assistance Programs and additional work/life resources
• Referral Bonuses and Tuition Reimbursement
• Flexible PTO
• Volunteer Time Off to benefit the community
• Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement

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.

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: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The accountabilities listed below are representative of the knowledge, skills, and/or ability required.

• 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:

Physical and Sensory Requirements: The physical and sensory requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be offered to individuals with disabilities to assist in performing the essential functions of the position. Work activities involve light to moderate physical effort (for example, sitting in one place for extended periods of time, standing, walking, bending, lifting lightweight objects, intermittent to sustained periods of keyboarding).  Majority of time is spent in a seated position with frequent opportunity to move about at will.  Activities require a variety of easy muscle movements.  Work activities involve a frequent need to concentrate on a variety of sensory inputs for moderate to lengthy durations at a time requiring diligence and attention to interpret effectively.  There will be a need to attend to single or simultaneous tasks where accuracy of details is important.  The need for detailed and precise work is high.