QA Associate

Red Nucleus is hiring a QA Associate to join our global compliance team! This role can be based out of our US offices, or full-time remote in the US. Candidates must be able to work EST hours.  

Our purpose is advancing knowledge to improve lives. We succeed by being the premier provider of strategic learning and development, scientific advisory services, and medical communications solutions for the life sciences industry. Our global team is composed of nearly 800 full-time employees whose commitment to creativity, quality, and on-time delivery is unrivaled in our space.

At Red Nucleus, we believe in providing a rich working environment that pushes us to innovate in ways that engages our employees to be their best selves.  Our culture is about meaningful work, a true sense of community, and fun.  We love to celebrate our people and we are proud to have been Internationally recognized as a “Great Place to Work".    

How You Will Contribute

The QA Associate will support Red Nucleus’ internal compliance and training needs as well as quality related compliance requirements (Change Controls, Deviations, Vendor Qualification Management, Internal Audits, External Audits, and UAT execution) of Red Nucleus Products.

The QA Associate will report to the QA Manager, Compliance and be responsible for internal compliance and training requirements, inclusive of the requirements to maintain UNIFY™, a learning management system, for internal Red Nucleus compliance and training purposes. The QA Associate will ensure that Red Nucleus training meets the highest applicable standards and regulatory requirements, and that Red Nucleus staff has the training to deploy best practices and standardized tools to remain compliant internally and to support client engagements (as needed).

Responsibilities include:

General

• Work in partnership with Business Unit (BU) Heads and other leadership to support New Hire Onboarding/Training.

• Support Compliance/Quality Assurance activities across all Red Nucleus Business Units

• Manage UNIFY™ administration for all of Red Nucleus to ensure all employees are compliant with training requirements.

• Support Red Nucleus Product teams with Compliance related activities.

New Hire Onboarding/Training

• Document and facilitate approval of new hire onboarding processes for training assignment.

• Act as UNIFY™ point of contact for new hire notifications from BambooHR and data collection from hiring managers, including prescribed Internal Training requirements.

• Create, facilitate approval of and maintain templates and forms necessary for consistent new hire data collection.

• Develop and maintain the Red Nucleus training matrix for SOPs and Internal Training, including facilitation of leadership approval of SOP and other training requirements.

• Oversee new hire completion and scoring of course Knowledge Checks as required.

• Provide guidance to new hires and current staff on usage of UNIFY™.

Compliance/Quality Assurance Support

• Develop and disseminate training status reports to BU heads to drive timely completion and escalate overdue training with appropriate members.

• Deploy knowledge checks for training to ensure learner comprehension.

• Maintain the Red Nucleus training matrix in partnership with Compliance/Quality Assurance.

• Issue controlled document training per the Red Nucleus training matrix.

• Assist with GxP Vendor Qualifications, Procedural Reviews, Internal Audits, External Audits, Change Controls for GxP systems, and deviations as needed.

• Manage and maintain KPI Trackers (QA Tracker Folder) for Change Controls, Document Requests/Revisions, Internal Audits, External Audits, Deviations/CAPAs, Vendor Management List, and Training Compliance.

• Coordinate and manage JD/CVs for Red Nucleus employees, ensuring up to date and aligned with templates.

• Assist with all Red Nucleus documents required for compliance (SOP, WI, Form, Guide, etc.)

• Manage and maintain compliance of Red Nucleus employees and contractors to required training; conduct internal audits and address findings as needed.

• Support Compliance needs by issuing deviations or other requirements to maintain compliance.

UNIFY™ Administration for Compliance/Training Purposes

• Maintain and execute continuous improvement of UNIFY™ as it pertains to processes and documentation needed to support internal Red Nucleus Training.

• Document, facilitate approval of, and maintain data standards, naming conventions and field usage best practices for users, groups, assets, curricula, learning collections, and assignments.

• Coordinate and confirm creation of new users in UNIFY™ (creation to be carried out by IT Support).

• Coordinate and execute setup of groups, assets, curricula, learning collections, and assignments in UNIFY™.

• Coordinate review and testing of new Internal Training content prior to assignment to users.

• Identify and document UNIFY™ user, group, content, and assignment data gaps and issues, including recommendations for prevention, resolution, and execution of fixes.

• Identify and document areas of potential data harmonization with other systems, such as BambooHR, including facilitation of potential harmonization discussions.

• Document and report bugs, issues and feature requests to appropriate UNIFY™ product team contacts.

• Draft and distribute internal training communications and reports, including new, pending, and overdue assignments.

• Maintain relationships with BU and Department leaders to identify potential training opportunities and requirements.

Red Nucleus Product Compliance Support

• Provide product support by testing/executing UATs as needed for Red Nucleus GxP Systems (UNIFY™, DirectusPRO™, iTakeControl®).

• Assist with document signature process/routing for final documents for validation activities.

About You

• Bachelor’s Degree Required.

• Minimum of 2 years of professional work experience in pharma-regulated industry or equivalent.

• Strong project/timeline management skills.

• Self-drive and proactive

• Strong process development and improvement skills.

• Learning Management System administration experience preferred.

• Highly organized and detail oriented.

• Proficient in Microsoft applications such as Word, Excel, Project, PowerPoint, SharePoint, Teams, and Visio.

What You Will Enjoy at Red Nucleus

• Competitive pay, incentives, retirement, and income security programs
• Comprehensive benefits and wellness programs focused on healthy lifestyles
• Generous paid time off, employee assistance programs and flexible work arrangements
• Performance driven environment including professional development and transfer opportunities
• People first culture fostering self expression, diversity, and a growth mindset
• Celebrations! We love to celebrate service anniversaries, holidays, diversity and inclusion events, project milestones and anything else that is meaningful to our employees
• Support of the community organizations you are passionate about
• Ongoing programs and events designed to bring our global team together

Diversity, equity and inclusion are valued at Red Nucleus and we believe we have a shared responsibility to provide equal opportunity and foster an inclusive spirit.  We do not discriminate on the basis of race, color, national origin, religion, caste, sexual orientation, gender, age, marital status, veteran status, or disability status.

To learn more about working at Red Nucleus, please visit Careers | Red Nucleus.

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