Remote Quality Control Data Review Associate – Biotech Radiopharmaceuticals | Entry-Level Friendly | Work From Home Opportunities

About arenaflex

At arenaflex, we believe that extraordinary work doesn’t have to come with extraordinary constraints. Our mission is to connect talented professionals with meaningful careers in the life sciences, biotechnology, and pharmaceutical industries — careers that change patients’ lives and transform the future of medicine. We partner with innovative organizations across the United States to build teams that drive groundbreaking research, development, and commercialization of therapies that target some of the most challenging diseases of our time.

The biotechnology sector is one of the fastest-growing industries globally, with radiopharmaceuticals representing one of its most exciting frontiers. Targeted alpha therapy, or TAT, is revolutionizing how we approach solid tumors, and organizations in this space are racing to bring next-generation treatments to patients who need them most. arenaflex is proud to support this vital work by connecting skilled professionals with the teams that make it happen. Whether you are an experienced laboratory professional looking to bring your expertise to a new challenge, or an emerging talent seeking a foot in the door of the biotech industry, arenaflex is your gateway to opportunity.

One of our trusted partner organizations is a dynamic biotechnology company headquartered in Indianapolis, Indiana, focused on developing innovative targeted radiopharmaceutical therapies. This organization is a wholly owned subsidiary operating with the independence and entrepreneurial spirit of a biotech startup while leveraging the resources and oncology expertise of a major pharmaceutical parent company. Together, we are working toward a shared goal: to improve survival rates and quality of life for patients with solid tumors through the power of targeted radioisotopes. Their lead asset is currently in advanced clinical testing for patients with gastroenteropancreatic neuroendocrine tumors, with earlier-stage trials underway for small cell lung cancer.

By joining arenaflex and connecting with this opportunity, you become part of a movement that is reshaping oncology treatment. This isn’t just a job — it’s a chance to contribute to science that saves lives.

Position Overview

arenaflex is actively recruiting a Remote Quality Control Data Review Associate to support a leading radiopharmaceutical organization. This role is ideal for detail-oriented professionals who are passionate about data integrity, regulatory compliance, and contributing to life-changing therapeutic development. While the position is remote-friendly for qualified candidates, please note that occasional on-site work at the Indianapolis, Indiana facility may be required, including up to 10% travel for training, collaboration, or special projects.

This is a unique opportunity to join a quality control team at the forefront of radiopharmaceutical manufacturing. As a Quality Control Data Review Associate, you will play a critical role in ensuring the accuracy, completeness, and compliance of data that supports the development and commercialization of targeted alpha therapy products. Your work will directly impact the safety and efficacy of therapies that reach patients around the world.

Whether you are an experienced data reviewer, a recent graduate with a strong scientific foundation, or a professional looking to transition into the pharmaceutical or biotechnology industry, this role offers a clear path into one of the most rewarding sectors in modern science.

Key Responsibilities

As a Quality Control Data Review Associate working with arenaflex and our partner organization, you will take on a variety of meaningful responsibilities, including:

• Quality Control Data Review: Conduct thorough reviews of quality control data to verify accuracy, completeness, and adherence to established standard operating procedures (SOPs) and regulatory requirements. Your attention to detail will ensure that every data point meets the highest standards of quality.
• Timely Data Assessment: Ensure that all quality control data is reviewed as quickly and efficiently as possible without compromising accuracy. Timeliness in data review is essential to maintaining production schedules and meeting regulatory milestones.
• Standard Operating Procedure Management: Participate in periodic reviews and updates of Quality Control Standard Operating Procedures. As the regulatory landscape evolves and manufacturing processes improve, you will help ensure that SOPs remain current, accurate, and aligned with industry best practices.
• Investigation Leadership: Lead and conduct in-depth investigations following standard operating procedures for out-of-specification (OOS) results and other quality issues identified in the quality control lab. Your investigative work will uncover root causes and drive continuous improvement.
• Investigation Documentation: Compose detailed investigation reports and collaborate with Quality Assurance and Quality Control management teams to propose corrective actions and preventive measures (CAPA) to prevent recurrence of quality events.
• Data Integrity Assurance: Maintain the highest standards of data integrity throughout all data review and investigation activities. You will be a guardian of accuracy, ensuring that every piece of information can be trusted and traced.
• Process Improvement: Proactively identify opportunities to improve both investigation procedures and data review processes. Your insights and recommendations will help shape a culture of continuous improvement within the quality control function.
• Cross-Functional Collaboration: Work effectively with stakeholders across manufacturing, regulatory affairs, quality assurance, and laboratory operations to ensure seamless communication and coordinated responses to quality events.
• Additional Responsibilities: Perform other duties as assigned by management, contributing to the overall success of the quality control team and the broader organization.

This position is a salaried role, generally working first shift. However, please note that extended hours or weekend work may be required based on the radiopharmaceutical manufacturing schedule. Candidates must be comfortable working with and around ionizing radiation, biohazardous materials, and hazardous chemicals as part of standard laboratory operations.

Essential Qualifications and Experience

To excel in this role, candidates should bring the following qualifications:

• Educational Background: A Bachelor of Science (BS) degree in Biology, Chemistry, Biochemistry, Microbiology, or a related scientific field is required. Candidates with advanced degrees (Master’s or PhD) may be considered with fewer years of professional experience, provided they have direct cGMP technical writing experience.
• Professional Experience: Five to seven years of experience in pharmaceutical, biotechnology, or other cGMP (current Good Manufacturing Practice) regulated environments is required. This experience should include hands-on work in laboratory settings, quality control, or related technical functions.
• Regulatory Knowledge: A thorough understanding of cGMP regulations, ICH (International Council for Harmonisation) guidelines, FDA requirements, and other regulatory processes related to investigations and data review is essential.
• Technical Writing Skills: Demonstrated ability to write clear, accurate, and detailed technical documents, including investigation reports, standard operating procedures, and corrective action plans.

Preferred Qualifications

While the following qualifications are not strictly required, they will significantly enhance your candidacy:

• Experience working with injectable drugs or radiopharmaceuticals is strongly preferred, given the specialized nature of the partner organization’s work.
• Familiarity with laboratory equipment maintenance and calibration procedures.
• Prior experience in a startup or small biotech environment, where flexibility and entrepreneurial thinking are valued.
• Knowledge of radiopharmaceutical manufacturing processes and regulatory requirements specific to this field.

Skills and Competencies for Success

Beyond formal qualifications, the ideal candidate will demonstrate the following skills and personal attributes:

• Multitasking and Prioritization: The ability to manage multiple workstreams simultaneously and prioritize tasks based on competing demands and workflow requirements is essential in this fast-paced environment.
• Safe Handling of Hazardous Materials: A strong commitment to safety and demonstrated experience safely handling hazardous materials, chemicals, and potentially radioactive substances.
• Organizational Excellence: Excellent organizational practices and meticulous attention to detail are required to manage the volume and complexity of data reviewed in this role.
• Analytical and Problem-Solving Skills: Strong analytical capabilities and a methodical approach to problem-solving will help you excel in investigations and root cause analysis.
• Communication Skills: Excellent written and oral communication skills are essential for drafting reports, collaborating with cross-functional teams, and presenting findings to management.
• Technical Proficiency: Strong working knowledge of computer programs and software systems, including Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and other data management tools.
• Self-Motivation and Independence: The ability to work independently with minimal supervision, take initiative, and drive projects forward is highly valued.
• Team Collaboration: A collaborative mindset and the ability to work effectively with diverse teams across multiple departments and locations.

Compensation and Benefits

arenaflex and our partner organization are committed to offering competitive compensation packages that attract and retain top talent. The estimated annual salary range for this position is $35,000 to $40,000, depending on experience, qualifications, and location. In addition to base compensation, we offer a comprehensive benefits package that may include:

• Comprehensive medical, dental, and vision insurance plans
• Retirement savings plans with employer matching contributions
• Paid time off, including vacation, sick leave, and holidays
• Flexible work arrangements and remote work opportunities where possible
• Professional development support, including tuition reimbursement and continuing education opportunities
• Life insurance, disability coverage, and other protective benefits
• Employee wellness programs and resources
• Career advancement opportunities within a growing organization

Specific benefits will vary based on the employing organization and may be discussed in detail during the interview process.

Work Environment and Company Culture

The culture at our partner organization — and by extension, the culture that arenaflex helps foster — is defined by a unique blend of entrepreneurial energy and scientific rigor. As a wholly owned subsidiary of a major pharmaceutical company, the organization maintains the agility and innovative spirit of a startup while benefiting from the stability, resources, and oncology expertise of a global industry leader. This creates an environment where employees can do meaningful work, see the direct impact of their contributions, and grow their careers in exciting new directions.

Team members are encouraged to bring their best ideas forward, take ownership of their work, and collaborate across disciplines to solve complex challenges. Diversity, inclusion, and a commitment to scientific excellence are foundational values. The organization believes that varied perspectives and backgrounds drive better outcomes, both in the laboratory and in the marketplace.

Work-life balance is a priority. The organization recognizes that employees perform their best when they have the flexibility to manage their professional and personal lives. Flexible scheduling, remote work options for eligible roles, and a supportive management approach are all part of the package.

Career Growth and Learning Opportunities

Joining arenaflex and our partner organization as a Quality Control Data Review Associate is more than just a job — it’s a launchpad for a long and rewarding career in the biotechnology and pharmaceutical industries. As an employee, you will have access to:

• On-the-Job Training: Comprehensive onboarding and continuous training in cGMP practices, radiopharmaceutical quality control, and regulatory compliance.
• Mentorship Programs: Opportunities to work alongside experienced scientists, quality professionals, and industry leaders who are committed to helping you grow.
• Professional Development: Support for continuing education, certifications, and attendance at industry conferences and events.
• Career Advancement Pathways: Clear pathways for growth into senior quality control roles, quality assurance positions, management opportunities, and specialized technical functions within the radiopharmaceutical field.
• Cross-Functional Experience: Opportunities to collaborate with teams across manufacturing, regulatory affairs, research and development, and clinical operations, broadening your skill set and career options.
• Industry Exposure: The chance to work at the cutting edge of radiopharmaceutical development, a field that is poised for significant growth and innovation in the coming years.

Equal Opportunity Employer

arenaflex and our partner organizations are committed to building diverse, inclusive teams where every employee feels valued, respected, and empowered to do their best work. We are proud to be equal opportunity employers and do not discriminate on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law.

How to Apply

If you are a motivated, detail-oriented professional with a passion for quality and a desire to make a difference in patients’ lives, arenaflex invites you to apply for this exciting opportunity. This is your chance to join a team that is pioneering the future of targeted radiopharmaceutical therapies while building a rewarding career in one of the most dynamic sectors of the life sciences industry.

To take the next step in your career journey, please submit your application today through arenaflex. Be sure to include your updated resume, a cover letter highlighting your relevant experience and qualifications, and any supporting documents that demonstrate your commitment to quality and scientific excellence.

Don’t miss this opportunity to be part of something extraordinary. Apply now and let arenaflex help you take your career farther than you ever imagined. The future of medicine is being written today — and your work could be part of the story.