At arenaflex, we're pushing the boundaries of innovation and excellence in the biotechnology industry. Our commitment to groundbreaking work and patient-centric approach has made us a leader in the field. We're now seeking an experienced Quality Control Data Review Specialist to join our team at RayzeBio, a cutting-edge radiopharmaceuticals development company. As a Quality Control Data Review Specialist, you'll play a critical role in ensuring the accuracy, completeness, and consistency of quality control data for our designated alpha treatment (TAT) radiopharmaceuticals.
**About arenaflex**
arenaflex is a pioneering biotechnology company that's revolutionizing the way we approach cancer treatment. With a strong focus on innovation and collaboration, we're committed to developing life-changing therapies that improve patient outcomes. Our team is passionate about making a difference, and we're looking for like-minded individuals to join us on this journey.
**About RayzeBio**
RayzeBio is a subsidiary of arenaflex, dedicated to developing innovative radiopharmaceuticals for the treatment of various cancers. Our team is comprised of experienced professionals who share a common goal: to improve patient lives through groundbreaking research and development. As a Quality Control Data Review Specialist, you'll be part of a dynamic team that's shaping the future of cancer treatment.
**Key Responsibilities**
As a Quality Control Data Review Specialist, your primary responsibilities will include:
* Auditing quality control data for accuracy, completeness, and consistency with established procedures and regulatory requirements
* Ensuring quality control data is reviewed as soon as possible
* Directing occasional surveys and updates of Value Control Standard Working Systems, as needed
* Directing examinations – leading and directing thorough examinations observing guideline working systems for out-of-spec results and other quality issues in the quality control lab
* Archiving examination findings – composing detailed examination reports and working with QA and QC management to propose corrective action and remedial training to prevent repeat occurrences
* Ensuring data integrity throughout data audit and examination processes, as required
* Proactively identifying opportunities for improvements to both examinations and data audit processes
**Position Requirements**
This is a salaried position, typically first shift, but may require extended hours or weekend work based on radiopharmaceutical production schedules. The position will require the candidate to work with and around ionizing radiation, biohazardous materials, and hazardous chemicals. Up to 10% of travel may be required.
**Essential Qualifications**
* BS in Science, Science, Science, or applicable field with five to seven years of experience in pharmaceutical or other cGMP experience
* Postgraduate education may be satisfactory with less experience, but direct experience in cGMP technical writing is required
* Careful understanding of cGMP guidelines, ICH regulations, FDA, and other regulatory examination process
* Experience with injectable drugs or radiopharmaceuticals is highly preferred
* Experience following maintenance of laboratory equipment is preferred
**Desirable Qualifications**
* Ability to perform multiple tasks and focus on work based on different work processes is an absolute necessity
* Ability to safely handle hazardous materials
* Good managerial practices are required
* Strong scientific and critical thinking abilities
* Ability to work well and communicate effectively with different partners
* Strong written and oral communication skills
* Ability to work with computer programs, including but not limited to Microsoft Office
* Highly energetic with the ability to work independently, without supervision, or with others in a team environment
**Benefits and Perks**
As a Quality Control Data Review Specialist at arenaflex, you'll enjoy a range of benefits and perks, including:
* Competitive salary and benefits package
* Opportunities for career growth and professional development
* Collaborative and dynamic work environment
* Access to cutting-edge technology and equipment
* Recognition and rewards for outstanding performance
* Comprehensive training and support
**How to Apply**
If you're a motivated and experienced professional looking to join a dynamic team that's making a difference in the biotechnology industry, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you!
**Equal Employment Opportunity**
arenaflex is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment that values diversity, equity, and inclusion.
**Disclaimer**
arenaflex is not responsible for any errors or omissions in the job posting. The company reserves the right to modify or withdraw the job posting at any time without notice.