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Quality Assurance Technician - 2nd/3rd shifts
Orca Bio
Quality Assurance
Sacramento, CA, USA
Posted on Feb 23, 2024
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 Quality Assurance Technician plays a critical role in supporting rapid processing times, providing on the floor quality assurance support for manufacturing. In this role, you will perform real-time record review of production records, equipment logbooks, and QC documentation. Additionally, this role will support real time manufacturing support, supporting issue resolution and documentation. This role will also support other quality processes, including quality document management, deviation system management, and CAPA as needed. You will have the unique opportunity to make a difference in the lives of many patients by ensuring that we deliver high quality products.
Positions are available on 2nd shift (12:30pm - 11pm) and 3rd shift (10pm - 8:30am), on a 4 X 10 schedule, beginning on Mondays, at our commercial manufacturing facility: 7910 Metro Air Parkway, Sacramento, CA.
Responsibilities
· Review routine and non-routine records / documents, ensuring records support good-documentation-practices and demonstrate cGMP
· Partner with manufacturing and technical resources to ensure records are complete and product quality impact rationale is complete to support batch disposition decision(s)
· Partner with manufacturing and technical resources to troubleshoot and address any equipment issues with production promptly to minimize downtime
· Routinely walk-through manufacturing and warehouse areas to confirm operations and the areas support cGMP operations
· Receive and provide coaching and training to personnel in the organization
· Perform a broad variety of basic and moderate complex tests in support of quality assurance activities as required
· Perform other duties as requested by supervisor/manager to support Quality operations
· Escalation of significant issues to organizational leaders as required
· Collaborate with cross-functional teams, including manufacturing, quality control, and quality assurance, to address environmental monitoring-related issues and implement corrective actions
Requirements
· Ability to wear cleanroom gowning and meet the requirements of the controlled, classified spaces
· Perform shift work to support 24-hour manufacturing operations
· Identify and support resolution of technical problems
· Actively participate in group and project teamwork; project and process improvements
· Resolve issues as needed with management approval
· Adhere to cGMP policies and procedures, including documentation activities
Desired Experience
· Classes in a relevant scientific discipline (biology, microbiology, environmental science, etc.)
· Excellent organizational, communication, and problem-solving skills
· Detail-oriented with a strong commitment to data integrity and accuracy
· Ability to work independently and as part of a team in a fast-paced and regulated environment
· Adaptable and responsive to changing priorities and challenges
· No experience is required, but experience in microbiology, environmental monitoring, aseptic technique, or GMP within a cell therapy or biopharmaceutical manufacturing environment 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 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.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
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.