Catalyx is seeking a Compliance Specialist to join our team in Fremont, Ca.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

We are seeking an experienced and driven Compliance Specialist to assist us with a major pharmaceutical client.

Responsibilities:

Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This position will support in the monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions.

Helps to Identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.

Skills and Experience:

Possesses knowledge in the area of manufacturing biopharmaceuticals.

Experience in managing simple to moderate projects, and CAPA.

Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions.

Some knowledge of change controls, deviations, project management, and audits/inspections.

Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.

Projects are cross functional, and the project scope is limited.

The specialist should be able to independently influence peers to achieve a common goal.

Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)

Time management:

Must be able to multi-task and be organized.

Experience in biotech and pharmaceutical manufacturing is a requirement.

Preferable experience being a manufacturing operator or technician.

Education:

Bachelor’s degree with a focus in Biopharmaceuticals.

Experience: 2 Years Experience with cGMP and biopharma.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.