Quality Assurance Specialist

Are you well-versed in all things Quality Assurance including assisting in the development, implementation, and maintenance of systems and activities? Do you have a knack for ensuring compliance with industry standards and regulations? Would you like to work in a global community focused on improving our world through better access to clinical research for all?

If yes, we would like to hear from you!

The Company

At Trialbee we are revolutionizing the patient recruitment ecosystem with technology, people, and passion. We are empowering clinical study teams with technology that improves clinical research outcomes while simplifying the patient journey into clinical research. With our innovative technology and services, we help biopharmaceutical and medical device companies match and enroll patients in clinical trials.

Trialbee works with a variety of customers and partners, across countries in Europe and in the US. Trialbee is driving global clinical trial enrollment by using SaaS platforms to enroll clinical trials on a global scale. Our flagship SaaS-based solution, Trialbee Honey, tracks all recruitment activities while optimizing enrollment with real-time analytics.

Trialbee consists of a global team of passionate professionals - all committed to digitally connecting stakeholders across the drug development chain, creating value for our clients, patients, and society.

The Role

We are seeking a talented and experienced professional to join our team as a full-time, remote-located Quality Assurance Officer. The successful candidate will work closely with the entire organization to ensure we're compliant with industry standards. If you want an exciting career in a growing company with growth opportunities, where you can use your academic skills or previous expertise while developing and growing your career even further, this is the opportunity for you!

Location: Europe.

Responsibilities

Document Control:

• Manage and maintain documentation related to Quality Assurance, including procedures, work instructions, and records.

• Ensure that all documents are reviewed, approved, and distributed according to the company's document control procedures.

Training and Development:

• Maintain the Trialbee University (LMS) system SkyPrep to ensure training of employees on Quality Assurance processes and policies are up to date and in line with the Trialbee Training Matrix .

• Support the development and delivery of quality-related training programs.

Vendor Management

• Manage the Trialbee vendor assessment process reviewing assessment questionnaires and approval of vendors.

Client Assessments and RFIs

• Assist in completion of client RFI or assessment documents in collaboration with the Sales Team.

Quality Systems Management:

• Assist in the development, implementation, and maintenance of the company's Information Security Management System (ISMS) in accordance with relevant standards (e.g., ISO 27001, GCP).

Compliance and Auditing:

• Support internal and external audits, including preparation, execution, and follow-up on corrective actions.

Process Improvement:

• Identify areas for quality improvement and work closely with the QA Director to develop and implement solutions.

• Work with relevant departments to ensure customer satisfaction and continuous improvement.

Non Conformances and CAPAs

• Assist in investigating non-conformances and CAPAs, identifying root causes, and implementing corrective and preventive actions.

Qualifications, Experience, and Skills

• Minimum of 3-5 years of experience in quality assurance, quality systems or a related field.

• Experience in software / cybersecurity quality standards and regulations.

• Working knowledge of GDPR, HIPAA, and other relevant health-tech standards.

• Fluency in spoken and written English.

• Values being #Humble #Kind #Curious #Fun.

• Strong understanding of quality assurance principles, methodologies, and tools.

• Excellent analytical and problem-solving skills.

• Attention to detail and a commitment to quality.

• Strong communication and interpersonal skills.

• Ability to work independently and as part of a team.

• Proficiency in MS Office and quality management software.

• Certified Quality Auditor or similar certifications are an asset.

Educational Requirements

• Bachelor’s degree in Quality Assurance, Engineering, or a related field preferred.

Life at Trialbee

At Trialbee, we are all passionate about making a difference as we innovate the future of clinical trial patient enrollment. We focus on patients, culture, and innovation, and joining Trialbee means joining a dynamic, tight team that works together in an inclusive environment across the globe.

What we offer:

• A global community of talented people working from 7 different countries
• A challenging and stimulating job in an exciting industry
• Competitive compensation package
• Flexibility
• A high-pace, high-energy, and high-performance environment
• Social gatherings and activities
• A friendly and supportive community of team members
  

Do you want to get involved in work that makes a difference in the world? Are you looking for a company where everyone has a voice? If yes, don’t hesitate to apply.

Diversity, Equity, and Inclusion

We’re an equal-opportunity company. All applicants will be considered without attention to ethnicity, appearance, religion, gender identity, sexual orientation, national origin, veteran, or disability status.