Salary Range: 70000 to 95000 (Currency: USD) (Pay period: per-year-salary)
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.
Key Responsibilities
- Provide oversight for Computerized System Validation such as analytical equipment and corporate systems such as electronic QMS systems.
- In collaboration with QA, sets requirements for the compliant execution of software validation and instrument qualification per regulatory expectations. Builds templates for efficient projects execution and streamline processes as needed.
- Setup small scale equipment and resolve data integrity gaps.
- Write, review and approve user requirement specifications, instrument risk assessments, operation, SOPs related to computerized systems for compliance to regulatory requirements.
- Maintain subject matter expertise and knowledge of industry practices for validation and qualification principles and theories related to computerized systems.
- Develop computer system compliance strategy, especially for FDA 21 CFR Part11 and Annex 11 compliance.
- Serve as SME for CSV audits, quality and regulatory audits for computerized systems in conjunction with QA compliance leaders and system owners.
- Responsible for the timely execution of all systems implementations, software validations and instruments qualifications, in a compliant manner and in alignment with established quality and regulatory requirements.
- Provides training for regarding systems applications as required.
- Supports and troubleshoots complex investigations related to computerized systems.
- Maintains the computerized validation status as part of validation life cycle.
- Completes periodic reviews on computerized systems per established procedure.
- Oversees the updates and maintenance of computerized systems on routine basis and evaluates new systems for implementation.
Desired Qualifications
- BS degree in a scientific or engineering discipline is preferred.
- Minimum of 3 years’ experience in pharmaceutical cGMP regulated environment, validation and qualification of equipment and computer systems in a pharmaceutical organization.
- Expert knowledge of CSV, analytical equipment, Master Control, Facility Maintenance System, and QC testing.
- Experience working on VHP (Vaporized Hydrogen Peroxide)
- Thorough knowledge of cGMP, 21CFR Part11 and Annex 11, as well as regulatory guidance related to data integrity.
- Excellent technical writing, experience in risk assessment, gap analysis, change control and deviation management.
- Excellent organizational skills and capable of multi-tasking.
- Ability to work independently with minimum supervision.
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.
