Quality Coordinator

Company Description

For over 20 years, Abcam has been providing tools the scientific community needs to enable faster breakthroughs in critical areas like cancer, neurological disorders, infectious diseases, and metabolic disorders.

We believe that to continue making progress, we need to work together in new ways. We need your own unique perspective as well as this of our people to make an always greater impact on the world. This community needs people like you: dedicated, agile and above all audacious so we can truly bring progress forward.

Job Description

We are currently seeking a motivated and detail-oriented Quality Coordinator to join our team in Fremont, CA. As a Quality Coordinator, you will play a key role in providing quality support to our In Vitro Diagnostic (IVD) team. This position offers a combination of laboratory and desk-based work. This is an on-site, 6-month contract role. 

Responsibilities:

• Maintain process compliance and ensure adherence to all procedures to ensure regulatory compliance.
• Support the generation of labels and production batch records (PBR) for manufacturing use, ensuring accuracy and completeness.
• Perform final review and release of production batch records (PBR) to ensure product quality and compliance.
• Assist in line clearance, receiving, and distribution activities, ensuring proper handling and documentation.
• Coordinate, perform, and review non-conformities (NC) in accordance with established procedures, identifying and addressing quality issues.
• Coordinate, perform, and review corrective action and preventive actions (CAPA) to prevent recurring quality issues and improve processes.
• Coordinate, perform, and review change control records (CR) to manage changes effectively and maintain compliance.
• Ensure timely and thorough filing of records to maintain a well-organized documentation system.

Qualifications

You have a Bachelor or Master Degree in Life Science with 2 years of relevant industry experience working under a quality management system (QMS) certified to ISO 9001 or ISO 13485. You have preferably worked under a certified quality management system (QMS) for over 3 years. 

You have excellent attention to detail, good organizational and communication skills with the ability to prioritize and work across several projects and to deadlines as part of a team. 

The ideal candidate for the Quality Coordinator position should hold a bachelor's or master's degree in a scientific or related field, with a preference for those who have 2 years experience in a regulated manufacturing environment, specifically in the field of In Vitro Diagnostics (IVD).

Familiarity with regulated environments such as ISO 13485 or ISO 9001. Attention to detail, excellent organizational skills, and the ability to work both independently and as part of a team are essential. Strong written and verbal communication skills, along with proficiency in Microsoft Office applications, are also required.

Additional Information

We know that when it comes to benefits, no one size fits all. Flexibility and choice matter which is why, in addition to market competitive salaries, we offer you a flexible benefits package which is tailored to your unique needs and support your financial, physical and emotional wellbeing. This includes our award-winning share scheme, 18 weeks fully paid maternity leave, 6 weeks fully paid paternity leave as well as highly flexible working and much more. Besides, your development will be integral to your experience here. You will grow alongside other talented minds, in ways you may often find unexpected.

When people come together, incredible things happen. Here you’ll work in a safe environment where you can be who you truly are. We’ll champion and celebrate your uniqueness throughout your journey with us. This is how we excel at partnering with the scientific community no matter the challenge, ultimately helping solve the world’s most critical diseases. Find out more about Diversity & Inclusion at Abcam.

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