Quality Assurance - Level 2
Illumina
Job Summary
At Illumina, a Quality Assurance Specialist in Cambridge (hybrid) supports Illumina Laboratory Services (ILS) in maintaining and improving a quality management system compliant with ISO 15189. This role is ideal for someone with a scientific background and a couple of years of lab experience, interested in a quality career. Responsibilities include providing QA support, ensuring process compliance, handling nonconformances, and contributing to process improvements.
Must Have
- Provide general quality assurance support, guidance, review, and approvals to areas of testing operations, supply chain, test development, or test quality.
- Ensure processes are carried out in accordance with policies, procedures, and requirements.
- Identify, resolve, and escalate deviations or potential test quality risks.
- Work directly with internal customers / other functions to resolve deviations and issues.
- Generate and analyze metrics charts and graphs.
- Contribute to the planning, prioritization, and assignment of workload to achieve goals and meet service levels.
- Experience of carrying out quality audits to an ISO (17025/15189/13485) standard is required.
- An understanding of quality systems, ISO 17025/15189/13485, is required.
- Some experience in Quality Assurance in the testing industry.
- General knowledge of statistical analysis.
- Bachelor's degree in an engineering, science or quality.
Good to Have
- Advanced degree desirable
- Quality certification desirable
Perks & Benefits
- Flexible time off
- Private medical insurance
- Compassion and care time off
- Leisure travel insurance
- Pension
- Employee stock purchasing program
- Volunteer time off
Job Description
What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Quality Assurance - Cambridge (Hybrid)
Closing date - Tuesday 2nd December 2025
This is a full-time, hybrid position with the opportunity for home working up to twice per week.
As a Quality Assurance Specialist, you will help support our Illumina Laboratory Services (ILS) in the maintenance and continual improvement of a quality management system that is in compliance with ISO 15189. This role is suitable for someone with a scientific background who might have been working in a lab for a couple of years, who is interested in a career in quality.
You will have great attention to detail, strong computer skills, and a good head for numbers. We are looking for people that are interested in the space, if you have been involved in audits in your current role and enjoyed it, this could be a great opportunity to progress your career.
Illumina's employee benefits are industry-leading and include, flexible time off, private medical insurance, compassion and care time off, leisure travel insurance, pension, employee stock purchasing program, volunteer time off, and much more!
Responsibilities:
- Provides general quality assurance support, guidance, review, and approvals to areas of testing operations, supply chain, test development, or test quality.
- Ensures processes are carried out in accordance with policies, procedures, and requirements.
- Assignments may include areas such as Nonconformance Reporting, Complaint handling investigations, Deviations, Incoming Reagent Quality, Control of Documents/Records, Equipment maintenance, Training & Competence, Audits, etc.
- May represent quality team as participant in core teams or on process improvement teams.
- Identifies, resolves, and where needed, escalates deviations or potential test quality risks. Works directly with other functions to resolve
- Works directly with internal customers / other functions to resolve deviations and issues.
- Generates and analyzes metrics charts and graphs. Recommends actions, develops and leads action plans and reports to local management.
- Contributes to the planning, prioritization, and assignment of workload to achieve goals and meet service levels.
- May be responsible for maintenance of local work instructions, SOPs and training required.
- Identifies and helps drive improvements.
- Operates with relative independence to achieve assignments within framework of goals, objectives, and policy/procedures.
- Applies acquired job skills and knowledge of company operations, policies, and procedures to complete assigned goals and objectives.
- Requires minimal instruction and/or supervision on new projects/ assignments or to resolve unexpected issues and deviations.
- Is considered an independent, first line resource for assessing and resolving issues.
Preferred background, skills and experience:
- Bachelor's degree in an engineering, science or quality; advanced degree desirable; quality certification desirable.
- Experience of carrying out quality audits to an ISO (17025/15189/13485) standard is required.
- Must be open minded, collaborative and able to work in a non-hierarchical environment.
- Must be able to look at processes high level as well as zoom in on a detailed level.
- Strong interpersonal skills and ability to articulate a motivating quality vision to others.
- Must be pragmatic in defining a quality path that achieves key goals while recognizing resource constraints.
- An understanding of quality systems, ISO 17025/15189/13485, is required.
- Some experience in Quality Assurance in the testing industry, general knowledge of statistical analysis.
- Excellent written, verbal and organizational skills required
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.