More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
The Specialist, Training works to develop, deliver and optimize classroom and hands on training programs that support the development and enhancement of skills related to GMP operations in a clinical or commercial manufacturing environment. The role ensures that personnel are trained effectively on standard operating procedures (SOPs), equipment use, safety protocols, and regulatory compliance to achieve production goals and maintain quality standards.
This is a 3rd shift-based position, working on-site Monday night through Friday morning, from 9pm to 7:30am.
Key Responsibilities:
Support employees and area management with MasterControl Training module navigation, reporting, and troubleshooting.
Manage the access and permissions to MasterControl Training module.
Manage the assignment, creation, maintenance, and removal of training curricula in the training system. Maintain a list of standard assignments by job title.
Maintain audit-ready training documentation. Ensure accurate employee training, certification, qualification records.
Provide reports and system training to ensure employee qualification status is clear to employees and functional management.
Facilitate onboarding of employees into the MasterControl Training Module.
Facilitate and deliver new employee onboarding training as necessary.
May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines
Minimum Qualifications:
High school diploma or equivalent required
2-3 years of experience in training administration, learning management systems, or a related field.
Strong understanding of GMP training requirements.
Proficiency in MasterControl or similar training management systems.
Excellent organizational and time management skills.
Ability to manage multiple projects and priorities simultaneously.
Strong communication and interpersonal skills.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Preferred Qualifications:
Associate’s degree or certifications in training strongly preferred
Experience with document control and policy creation is a plus.
The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
