Training Coordinator

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 Training Coordinator is responsible for facilitating the day-to-day operation of the training systems, including training files and records, curriculum assignments and tracking, reporting and scheduling of training activities. This role supports Good Manufacturing Practices (GMP) related to training in Orca clinical and commercial organization. The training coordinator works closely with quality, planning and manufacturing to ensure compliance with regulatory standards.

Responsibilities

• Maintain accurate training records and files of all training activities, certifications and employee process 
• Manage the assignment, creation and removal of employee training curriculum in the Training System 
• Maintain a job code matrix in line with requirements for various employee positions 
• Facilitate the creation of job codes that include the appropriate learning content of standard operating procedures, work instructions, certifications 
• Prepare and distribute training reports, including compliance metrics and follow up on actions needed to maintain compliance 
• Scheduling and tracking of training sessions to ensure employees receive required GMP trainingin a timely manner 
• Support employee training sessions as required 

Education & Experience Requirements

• High school diploma or equivalent required
• Associate’s degree or certifications in training strongly preferred
• 2-3 years of experience in manufacturing related operations, in biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
• Experience with on-the-job training, or training systems a plus
• Prior experience in regulated, GMP manufacturing operations is a plus
• Strong communication and problem-solving skills, organizational skills

Personal Qualities & Physical Demands

• Highly detail oriented with special attention to quality, compliance and safety
• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment 
• Strong interpersonal skills and ability to communicate effectively
• Ability to work in a collegial and collaborative manner, independently and part of a team
• Ability to work in a fast-paced start-up environment while following SOPs
• Highly tolerant and respectful of all team members
• Strong problem-solving skills with desire to improve upon established processes
• Ability to gown into cleanrooms and follow clean room protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
• Physical demands include standing, walking and working at a desk

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 medical, dental, and vision benefits, flexible PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include free 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.