Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, clinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.
We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.
Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.
The QS Specialist II is responsible for Quality System activities that directly support execution of global processes. The incumbent will support one or more key quality systems, with a focus on documentation and training process support. We are seeking a highly motivated individual to join us and assist with document processing and process enhancement; work closely with stakeholders to execute workflows and support maturing business processes that align with best practices that ensure right first time. This role may also include support for phased appropriate aspects of deviations, CAPA, change control, and auditing. The successful candidate is proficient in communication (written and verbal), multitasks across multiple functional quality system areas, is a time-line focused and flexible in their work schedule. This role is an on-site position based in Santa Monica, California.
Essential Functions and Responsibilities
Responsible for overall documentation issuance (such as, but not limited to procedures, test methods, specifications, validations, and study plans & reports); data entry and archival processes to support documentation and training activities.
- Collaborates with cross-functional departments, to ensure timely implementation of document change requests.
- Write and initiate changes to controlled documents (e.g., SOPs, manuals, forms, and training material) for document and records management processes
- Serve as EDMS super user, assist & troubleshoot customer issues
- Ensures accuracy by reviewing documents for completeness, proper authorization, and impact to other quality systems.
- Support audits (internal, external)
- Update and create training curriculum revisions as needed
- Interact with functional departments to establish priorities and deadlines for documentation and records
- Perform other duties and special projects as assigned
- Strong verbal and written communication skills.
- Strong organizational skills, and attention to detail.
- Ability to function well in a high-paced environment.
- Proficient with Microsoft Office Suite or related software.
- Knowledge of GMP/GCP/GLP SOPs and quality system processes.
- Working knowledge of global GxP regulations
- Ability to communicate and work independently with scientific/technical personnel at all levels.
- Experience in pharmaceutical or bio-pharmaceutical field.
Education and Experience
5+ Years with High School 2+ Years with BS/BA;
1+ Years with MS/MA or Eng Degree
The anticipated salary range for candidates who will work in Santa Monica, CA is $70,000 to $82,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.
Note: At this time, Neogene is not sponsoring VISAs.
Headline: We embrace our individual differences.
"Our mission is to build a workforce reflective of our communities to be receptive to patients' broad and unique perspectives, enabling us to empathize with their needs. Together, we strive to uphold a value system that promotes:
- Opportunities for continuous learning to drive behavioral change and to be respectful of other points of view
- A collaborative culture that leverages the diverse perspectives of employees and supports courage
- Zero tolerance for discrimination
We are committed to an emotionally and psychologically safe workplace that trusts employees to boldly explore innovative solutions. We recognize that intentionally embracing diversity at Neogene, empowers us to better relate to patients, and advance our mission to deliver cures where none exist.”