Experienced Quality Control Data Reviewer – Pharmaceutical and Biotechnology Industry Professional with Strong Analytical and Communication Skills

Introduction to blithequark

At blithequark, we are committed to making a significant impact in the lives of patients and the careers of our employees. As a leading organization in the pharmaceutical and biotechnology industry, we offer a unique work environment that is both challenging and rewarding. Our team is dedicated to improving the survival of individuals with cancer by harnessing the power of targeted radioisotopes. We are seeking a highly skilled and motivated Quality Control Data Reviewer to join our team and contribute to the development and commercialization of our innovative treatments.

Job Summary

We are looking for a meticulous Quality Control Data Reviewer to play a critical role in the review and analysis of Quality Control data for accuracy, completeness, and compliance with established procedures and regulatory requirements. The successful candidate will have earlier laboratory and technical experience in the radiopharmaceutical industry, with a strong understanding of cGMP regulations, ICH guidelines, and FDA processes.

Key Responsibilities

• Review Quality Control data for accuracy, completeness, and compliance with established procedures and regulatory requirements
• Ensure Quality Control data is reviewed in a timely manner
• Conduct periodic review and updates of Quality Control Standard Operating Procedures, as needed
• Lead and direct in-depth investigations following standard operating procedures for out-of-specification results and other quality issues in the quality control lab
• Document findings of investigations – write detailed investigation reports and work with QA and QC management to propose corrective action and remedial training to prevent repeat occurrences
• Ensure data integrity throughout data review and investigations, as required
• Proactively identify valuable opportunities for improvements to both investigations and the data review processes

Requirements and Qualifications

The ideal candidate will have a BS in Science, Biology, Chemistry, or a related field, with 5-7 years of experience in the pharmaceutical or biotechnology industry, or other cGMP experience. Postgraduate degrees may be acceptable with less experience, but direct experience in cGMP technical writing is required.

• Strong understanding of cGMP regulations, ICH guidelines, and FDA processes
• Experience with injectable drugs or radiopharmaceuticals is strongly preferred
• Experience with maintenance of laboratory equipment is preferred

Skills and Competencies

The successful candidate will have the following skills and competencies:

• Ability to multitask and prioritize work based on multiple workflows
• Ability to safely handle hazardous materials
• Good laboratory practices are required
• Strong analytical and problem-solving skills
• Ability to work well and communicate effectively with different stakeholders
• Strong written and oral communication skills
• Ability to work with computer programs, including but not limited to Microsoft Office
• Highly motivated with the ability to work independently, without supervision, or with others in a team environment

Career Growth Opportunities and Learning Benefits

At blithequark, we are committed to the growth and development of our employees. We offer a wide range of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. As a Quality Control Data Reviewer, you will have the opportunity to work with a talented team of professionals, develop your skills and expertise, and contribute to the development of innovative treatments that improve the lives of patients.

Work Environment and Company Culture

Our work environment is dynamic, fast-paced, and collaborative. We value diversity, equity, and inclusion, and we are committed to creating a workplace culture that is respectful, inclusive, and supportive of all employees. We offer a range of benefits, including flexible working hours, professional development opportunities, and a comprehensive compensation package.

Compensation, Perks, and Benefits

We offer a competitive salary range of $35-40 per year, depending on experience. In addition to our comprehensive compensation package, we offer a range of benefits, including health insurance, retirement savings, and paid time off. We also offer a range of perks, including flexible working hours, professional development opportunities, and a dynamic and supportive work environment.

Conclusion

If you are a motivated and skilled Quality Control Data Reviewer looking for a challenging and rewarding role in the pharmaceutical and biotechnology industry, we encourage you to apply for this exciting opportunity. At blithequark, we are committed to making a significant impact in the lives of patients and the careers of our employees. Join our team and contribute to the development of innovative treatments that improve the lives of patients.

To apply for this role, please click on the link below. We look forward to receiving your application.

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