Quality Control Technician II

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health, and addressing vision-related social issues for people around the world. Santen USA, headquartered in Emeryville, Calif., is an important part of our worldwide efforts and is home to our regional business teams. We have about 350 total employees in North America, including our other offices located in Toronto, Canada, Fort Worth, TX and Miami, FL. For more, visit https://www.santenusa.com/.

This position acts as a vital role in performing activities required by the Quality Management System and Quality Control System. Ensuring continued compliance to regulatory and/or internal standards and identifying compliance issues or non-conformances. This role will identify areas for improvement and implements procedural updates under the supervision of quality engineers and management.  This role will be responsible for the daily management of the Calibration System and the Equipment and Tooling System.

Functions and Responsibilities:

• Identifies opportunities for improvement and implements process changes.
• Uses SAP to manage product movement and release at Quality Control.
• Uses Veeva Quality Docs to create Engineering Changes and create and/or update documents as necessary.
• Provides input on department document revisions and coordinates document approvals.
• Review and Approve Documents.
• Regularly reviews technical documents used to support root cause investigation or product impact statements to ensure they align to current quality standards and procedures.
• Reviews and approves batch records for compliance to internal standards.
• Maintains equipment program by reviewing and approving new and current calibration and maintenance records. 
• Performs calibration and/or maintenance of critical equipment in accordance with internal/external standards.
• Creates and executes IQ/OQ/PQ validation protocols and writes reports detailing the results.
• Initiates investigations and root cause analysis for completion of NCRs or CAPAs.
• Supports internal and external audits, inspections, inspection readiness, certifications, and process monitoring and trending activities.
• Ensures all product release activities comply to internal requirements and issues Certificate of Conformance for outgoing product.
• Supports and maintains the Environmental Monitoring System to ensure compliance to internal requirements.
• Maintains a working knowledge of ISO 13485 and its application to internal procedures.
• Trends and analyzes data using statistical techniques, identifying any adverse trends and escalating as necessary.
• Supports Quality Engineering projects under the guidance of quality engineers.

• A minimum of one (1) year of related experience in medical device, biopharmaceutical or a pharmaceutical industry.
• Knowledge/experience with regulatory requirements, policies and guidelines (ISO 13485, ISO 9001, CFR Part 820).
• Computer, Microsoft word and excel skills are required
• Basic mathematical and computational skills

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19. Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit https://www.santenusa.com/career-culture.