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.

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. 

Are you passionate about ensuring quality and compliance in a dynamic manufacturing environment? Do you excel in leading teams towards excellence in quality control? Join our team as a Supervisor, Quality Control and play a pivotal role in upholding our commitment to producing high-quality reagents that meet Federal/State regulations and ISO standards.

In this hands-on leadership position, you will oversee the Quality Control team, ensuring strict adherence to our company’s quality system requirements. You will be instrumental in executing validation studies, investigating non-conformances, and tracking and trending the health of our manufacturing processes. Additionally, you will conduct training on quality-related tools, fostering a culture of continuous improvement within your team.

If you have a keen eye for detail, a passion for quality, and the ability to lead and inspire your team, we invite you to apply for this exciting opportunity!

The Opportunity

Timely formulation and quality control (QC) release of GenMark products and batch record reviews.

Conduct and supervise QC testing for product release, validation, and stability studies.

Execute protocols, analyze data, generate reports, investigate non-conformances, and implement QC process improvements.

Provide training for staff, identify and address cGMP/QS training needs, and ensure QC staff proficiency.

Communicate major QC issues to management and affected departments, and interface on quality-related issues with R&D, QA, Supply Chain, and external stakeholders.

Approve QC-related documents and records, and review and release manufacturing work orders per ERP system specifications.

Coordinate and schedule QC activities, participate in CAPA projects, and assist with special projects and additional duties as required.

Who you are

Bachelor’s Degree in life sciences or engineering 

Minimum of five (5) years relevant experience in a QC and/or manufacturing capacity

Skills – Technical

Thorough understanding of GMP, GLP, ISO, and FDA requirements; knowledge of Quality System Regulations and safety precautions for biohazards.

Technical expertise in molecular biology, pipetting, solution formulation, and experience with genetic databases, nucleic acid hybridization, and gene sequence amplification.

Experience in designing, coordinating, and documenting controlled studies, including protocol development and basic statistical analysis tools.

Proficiency in problem-solving methodologies and providing complex solutions to technical challenges.

Skills – General

Proven ability to handle and resolve conflicts and work under schedule/milestone pressures 

Ability to lead and work in a multi-functional team environment

Demonstrated ability to lead fast-track investigations through analysis to outcomes for decision

Demonstrated ability to be flexible and resourceful

Good communication, technical writing, and diplomacy skills

Strong problem-solving, judgment, and decision-making skills

CERTIFICATIONS, LICENSES, REGISTRATIONS

ASQ Certification as CQT, CQE, and/or CQA preferred; RAPS certification as RAC or AAMI certification a plus

1ST SHIFT INFORMATION: 5:00 a.m. to 2:30 p.m.

Relocation Benefits are not available

The expected salary range for this position based on the primary location of California is $72,200-$134,000.  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

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.  As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses.  GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark 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.