Quality Assurance Coordinator

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Abcam one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Progress happens together

At Abcam we believe the scientific community goes further faster when we go there together. Thats why we work with life scientists to provide biological reagents and solutions that enable faster breakthroughs in critical areas like cancer neurological disorders infectious diseases and metabolic disorders. Our talented team of over 1400 colleagues worldwide is our greatest asset. By applying our expertise and pushing boundaries together we strive to better serve our customers strengthen our impact across our industry and ultimately our positive impact on society.

Learn about the Danaher Business System which makes everything possible.

The Quality Assurance Coordinator is responsible for managing controlled quality documentation within an electronic QMS supporting internal audits and ensuring compliance with established quality standards. This role involves reviewing and approving key quality documents monitoring supplier performance and driving continuous improvement initiatives across processes and products. Additionally the coordinator facilitates quality forums supports training programs and assists in maintaining a strong culture of quality and safety throughout the organization.

This position reports to the Quality Assurance Manager and is part of the Regulatory Affairs and Quality Assurance department located in Waltham Massachusetts and will be an on-site role.

In this role you will have the opportunity to :

Manage controlled quality documentation through the electronic QMS and ensure timely review and approval of key records such as Certificates of Analysis and batch manufacturing documents.

Support internal audits non-conformance investigations and corrective / preventive actions to maintain compliance with the Quality Management System and drive continuous improvement.

Assist with quality training programs supplier performance monitoring and cross-functional forums to promote a strong quality culture and adherence to health and safety policies.

The essential requirements of the job include :

A degree in biological sciences or equivalent professional certification in quality management systems.

2 years experience of working within the Life Science or Medical Device Industry.

A working knowledge of quality systems such as ISO 9001 : 2015 and ISO 13485 : 2016.

It would be a plus if you also possess previous experience in :

Operational Excellence programs like LEAN Six Sigma Toyota Production Systems or Danaher Business Systems

Audit certifications for ISO 9001 or ISO 13485.

Abcam a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range OR the hourly range for this role is $35 / hour. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus / incentive pay.

We offer comprehensive package of benefits including paid time off medical / dental / vision insurance and 401(k) to eligible employees.

Note : No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

For more information visit .

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and / or to receive other benefits and privileges of employment please contact : 1- or .

Required Experience :

IC

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Industry,ICH Q7,ISO 9001,Hospice Care,Food Processing,Quality Management,cGMP,QA / QC,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1