Full-Time QC Specialist/Analyst II
Title: QC Specialist/Analyst II
Location: Waltham, MA
Reports to: Senior Manager, QC
AlloVir is a publicly held, high-growth biotechnology company pioneering science in the field of virus-specific T cell (VST) therapies.
We embrace a shared mission to prevent and defeat life-threatening viral disease, champion truth, and challenge the status quo in pursuit of constant improvement.
Our innovative spirit lives beyond the lab, in a world where patients fighting viral infection have access to revolutionary allogeneic cell therapies. A world where everyone has access to a healthy immune system.
Success in this role means partnering across the organization to establish an innovative cell therapy manufacturing supply chain, taking a pro-active approach to identifying and overcoming risks and barriers, and challenging in the pursuit of continuous improvement.
At AlloVir, the expectation is that regardless of title, people are both group leaders and individual contributors. Much like medicine, we believe that this person can both do the work and set the work, working across functions seamlessly, sometimes in the lead position sometimes in support.
This position is responsible for all aspects of quality control sample and data management for test results coming from AlloVir’s external network of contract QC testing laboratories. Reporting to the Senior Manager of Quality Control, he/she ensures sample receipt and handling of sample results/data are in accordance with current Good Manufacturing Practices (cGMP), including FDA, EMA and ICH guidelines.
- Monitor and manage sample shipment and receipt to ensure samples are delivered on time and in the appropriate shipping conditions
- Review executed test results, transfer data into LIMS or other designated tool, and generate Certificates of Analysis to support timely product disposition
- Establish standard work practices and visual management for sample and data management and laboratory controls as applicable to contract test laboratory oversight
- Participate in writing, reviewing and approving test records, Standard Operating Procedures, change controls, deviations and other technical reports/studies as needed
- Bachelor’s degree in a science or technical field and 2-4 years of experience of related biopharmaceutical GMP work experience, or Master’s degree and 0-2 years of work experience. Minimum of 2 years of GMP laboratory experience.
- Knowledge of LIMS system preferable
Why join AlloVir?
AlloVir is the global leader in developing novel cell therapies that restore natural immunity against life-threatening viral diseases for immunocompromised patients.
We have an innovative pipeline of allogeneic, off-the-shelf, T-cell therapies that treat and prevent many devastating and life-threatening viral diseases. Our technology and manufacturing process enables the potential for the treatment and/or prevention of up to six devastating viruses with each single allogeneic cell therapy.
As part of the ElevateBio portfolio of companies, you’ll have access to award-winning facilities with centralized cell and gene therapy manufacturing capabilities that help advance the development of our revolutionary therapies for immunocompromised patients.
Join a team committed to scientific excellence, focused on passionate engagement, and united in purpose to treat and defeat viral diseases.
At AlloVir, we are committed to fostering and expanding diversity in the workplace. We strive to create an environment where everyone feels a sense of belonging and differences are celebrated as strengths. With a company vision of “ImmUnity for all”, we place special emphasis on unity, on equality, and on inclusion for all employees, patients, and partners.
AlloVir is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. AlloVir will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
How to ApplyPlease apply on this site or our career site: https://www.allovir.com/careers
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