CQA Document Control Associate

Position Title: CQA Document Control Associate

Department: Clinical Quality Assurance

Ora Values the Daily Practice of …

Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor

At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

The Role:

Our global Clinical Quality Assurance (CQA) Document Control Associate will support our Quality Management team to ensure accuracy and efficiency throughout every aspect of the Quality Document Control system. This position provides support to the CQA Document Control Specialist and is responsible for maintaining electronic training files and tracking compliance across the company, in accordance with guidelines and regulations. This position requires a strong organizational background to assist in maintaining Ora's EMS and providing companywide support for training tracking, assignment, and reporting. In this role, you will be trained on preparing, updating/revising, and maintaining all Quality Management System Documents (procedures, policies, work instructions, forms, templates, and manuals) in addition to maintaining tracking reports to present metrics for Key Performance Indicators to report to Ora's Senior Management team.

What You'll Do:

• Ensure, with supervision, proper maintenance of clinical documentation databases and systems
• Assist with running reports and tracking status of Quality Assurance metrics
• Assist with change management for Quality document revisions
• Assist with editing documents needed for the QMS
• Upload, assign, and track training within Ora's Electronic Management System (EMS)
• Review external distribution requests, obtain approvals, and distribute documents utilizing Ora's approved document sharing platform
• Assist CQA Document Control Specialist with managing EMS user accounts, training records, system access issues, uploading QMS and study-specific documents
• Maintain adequate records of all Quality and operational documents
• Travel requirements less than 10% domestically
• Adhere to all aspects of Ora's quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
Clear and sustained demonstration of Ora's values
• - prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • Bachelor's degree in Life Sciences or a minimum of 1 year experience in Quality-related field. Years of experience may be considered in lieu of education.
  • Experience working with document management/training software applications
• Additional Skills and Attributes:
  • Familiarity with the clinical trial process and clinical Quality Assurance
  • Experience in other areas of GCP/GLP/GMP Quality Assurance
  • Competency in Microsoft Office Word, Excel, and Outlook applications
  • Ability to work well in a team environment and follow procedures
  • Strong commitment to the accomplishment of tasks
  • Ability to work in a fast-paced environment
  • Exceptional attention to detail with emphasis on accuracy and quality
  • Excellent verbal and written communication skills
  • Excellent organization and time management skills
  • Strong interpersonal and customer service skills

• Competencies and Personal Traits:
• • What We Do:
  • • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.
  • How We Do It:
  • • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
  • • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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