ConcertAI is the leading provider of precision oncology solutions for biopharma and healthcare, leveraging the largest collection of research-grade Real-world Data and the only broadly deployed oncology-specific AI solutions. Our mission is to improve translational sciences; accelerate therapeutic clinical development; and provide new capabilities for post-approval studies to accelerate needed new medical innovations to patients and to improve patient outcomes.
ConcertAI has emerged as one of the highest growth technology companies in Real-world Data and AI, backed by industry leading private equity companies: SymphonyAI, Declaration Partners, Maverick Ventures, and Alliance|Bernstein.
We are seeking a highly proficient Quality Assurance Specialist to coordinate and maintain the SOPs, QA Documents and Training programs, to ensure adherence to internal and regulatory requirements.
- These responsibilities include but are not limited to:
- Help with SOPs.
- Work with Quality team members to create; handle review and approval of documentation including policies and standard operating procedures (SOPs) as per the internal and applicable regulatory environment.
- Champion the Training Program.
- Understand the workings of Training Management System.
- Collaborate with various department heads to tailor the training plans.
- Provide trainings to new and existing staff in quality system requirements and applicable regulations.
- Conduct user on-boarding and training sessions, as needed.
- Identify issues and trends for system, procedure, and training improvements.
- Collaborate with document authors to develop appropriate training materials and questionnaires.
- Other duties include
- Track, investigate and maintain Quality documents and records (e.g. deviations, CAPAs, change control, documents, audits, approved vendors) to ensure compliance with internal and external requirements.
- Maintain various logs such as CAPA, Deviations, Audit, Vendor, SOP, Form and others.
- Support and advice departments on document system requirements and workflows.
- Support audits, as requested.
- Assist QA with other projects and tasks, where applicable.
- Participate in quality and process improvement initiatives and project teams.
- Excellent organizational skills, excellent oral and written communication skills.
- Other duties as assigned.
- Associate's degree or equivalent from two-year college or technical school with three to four years GCP or Pharma related experience and/or training.
- Be proficient in Microsoft Word, including document formatting, application of styles and numbering, tracked changes and comments.
- Have comprehensive knowledge of good documentation practices and document control concepts.
- Have basic knowledge of quality assurance principals, and best practices.
Learn More About ConcertAI
ConcertAI is transforming how healthcare is delivered and dedicated to improving patient outcomes in oncology by offering innovative solutions on how data and intelligence is used to solve healthcare problems. We are creating something special in our culture, by building a collaborative, engaged, patient focused, team approach to our mission. Our high-performance teams are looking to add great talent to the mix and we are hiring for the right mix of new skills and diverse mindset. Learn more about ConcertAI at www.concertai.com or on LinkedIn.