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Quality Control Associate Fulltime
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The Quality Control Associate – Sequencing Cartridge Operations will be an integral part of a team that performs cartridge assembly and systems testing. This individual will be responsible for the setup, execution, monitoring and data analysis of all Quality Control release activities associated with the Roche Sequencing Process.
The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment. The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP). Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members.
The opportunity:
• You are preparing sequencing platform equipment, testing equipment and materials as required per procedure and performing setup, execution and monitoring of Sequencing process for the Quality Control release of cartridge assemblies.
• You are responsible for conducting data analysis of test results and determining Quality acceptability per approved procedures and generating compliant QC documentation as part of the Device History Record, observations, test results and reports required for releasing items into inventory.
• You are performing a variety of QC duties relating to production manufacturing, including incoming and in-process QC inspections.
• You are maintaining records, equipment and QC lab environment to comply with cGMP, OP and regulatory requirements
• You are supporting design transfer from Development, procedures creation, process implementation, trouble-shooting, data monitoring, 6S effort and continuous improvement to streamline overall operations and improve efficiency
Who you are:
• You hold a High School Diploma with 4 years of related experience (Associate’s Degree with 3 years of related experience or Bachelor’s Degree with less than 1 year of experience preferred)
• You have hands on exprience in a laboratory,
• You have accurate and precise manual pipetting and measuring techniques
• You know how to utilize electronic office suite of computer programs
Preferred:
• Experience working in GLP, cGMP or ISO regulated environment; and Lean techniques
• Experience with handling corrosive and biohazardous reagents. Environment may require gowning, hair net, safety glasses, gloves and foot coverings, and may work with hazardous materials and chemicals
• Schedule could include overtime and shift work in the future as business needs require
• Lifting up to 25lbs may be required
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of California is 55,200.00 to 102,600.00 USD Annual . Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
