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15 days old

Associate, Technology QA & Compliance (Remote)

WIRB-Copernicus Group (WCG)
Work Remotely

General Information

Location: Plymouth Meeting, PA

Organization: WCG

Job Type: Full Time - Regular

Description and Requirements

Why work at WCG? There are so many reasons to join the WCG family!
We offer very competitive salaries and bonus opportunities, plus an extremely comprehensive bonus package - one of the best in the industry! It's our mission to help streamline and make clinical trials more efficient, so you'll be a part of some of the most cutting-edge therapies and science that is helping to make the world a better place! 

As an Associate, Technology QA & Compliance you will be responsible for assisting and supporting the Compliance team with respect to establishing and maintaining quality assurance standards and measures across WCG Technology services organization (Information Technology, Software Development) and ensuing such standards comply with regulatory requirements and best practice. This position is responsible for working alongside senior compliance team and WCG employees to ensure the CSO organization remains compliant with WCGs Quality Management System and technology processes.

Vaccination:
To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.

Your Role:
  • Support the continued development, maintenance, and enforcement of the CSO Quality Management System.
  • Lead efforts with regard to the successful implementation of CSO quality goals, objectives, and process improvements.
  • Assist Senior compliance team members to establish and enforce CSO quality department standards.
  • Train WCG staff on CSO quality department standards and best practices.
  • Engage with WCG staff to author and revise internal technology standards (i.e., IT and/or Software Development Policies, SOPs, et al). 
  • Lead assigned work and provide quality oversight over the implementation, and/or development, of WCG systems.
  • Support the implementation and execution of Computer System Validation, including the review of Validation deliverables, related to the implementation, and/or development, of WCG systems.
  • Ensure the implementation, development, and change management of such systems 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.
  • Support the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF).
  • Ensure proper investigation of such events is performed, and documentation maintained.
  • Assist in the conduct of internal audits to ensure that internal standards and staff performance are in compliance with applicable WCG process, regulatory agency regulation and guidance.
  • Assist with internal audits/periodic review of company policies and procedures.
  • Assist in internal audits/periodic review of WCG systems.
  • Identify compliance gaps and provide support and suggestions for remediation. Report status of the quality levels of staff, systems and production activities to the VP, IT Compliance. 
  • Assist in the conduct of external vendor qualification audits to ensure vendor standards and performance are in compliance with applicable WCG process, regulatory agency regulation and guidance.
  • Develop vendor audit plans, reports, collection of responses, and follow up.
  • Assist and support the hosting of external audits and inspections including audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution. 
  • Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.
  • Provide training and guidance to staff regarding compliance and interpretation of regulations.
  • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
  • Attendance and punctuality are essential functions of the position.

What You Will Bring:
  • Bachelors degree or local equivalent in medicine, science, technology, or equivalent degree/experience.
  • Two - Four (2-4) years experience in a quality/regulatory compliance position with evidence of increasing responsibility.
  • Knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical trials.
  • Familiarity and experience with audit preparation as well as assisting/facilitating customer and/or process audits.
  • Knowledge of 21 CFR Part 11 requirements and Computerized System Validation processes including SDLC.
  • Experience in the execution of Computerized System Validation of Clinical Systems.
  • Demonstrated technical writing skills.
  • Familiar with training others on standards and ensuring compliance with employee education/LMS.
  • 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.
  • Ability to problem solve and engage in the resolution of conflicts.
  • Ability to multitask and to work efficiently and independently.
  • Proficiency with a learning management system as well as MS Word, MS Excel, and MS PowerPoint.
  • Positivity, ability to problem solve, eagerness to learn, team collaboration and enthusiasm to  our mission-driven company!
What We Offer:
WCG offers competitive base pay and an annual bonus with a comprehensive benefits package (one of the best in the industry!). You will also work with excellent teams in an environment that thrives on innovation and forward-thinking. Looking for advancement? WCG offers many growth opportunities within the company through internal promotion! Benefits include:
  • Robust medical, dental and vision plans within 30 days of employment
  • 20 PTO days to start and 12 paid holidays annually
  • Matching 401K program
  • Tuition reimbursement
  • Much, much more!!!
Commitment to Diversity & Inclusion:
WCG is very proud to be an equal opportunity employer! Qualified applicants will receive consideration for employment without regard to race, color, national origin or ancestry, religion or creed, sex, sexual orientation, gender identity, age, marital status, disability, genetic information, citizenship, veteran status, reprisal or any other legally recognized basis or status protected by federal, state or local law. 

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Posted: 2022-07-27 Expires: 2022-08-28

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Associate, Technology QA & Compliance (Remote)

WIRB-Copernicus Group (WCG)

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