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.
Position Summary:
The Quality Ops Analyst is responsible for day-to-day administration of Illumina’s Quality Assurance programs in support of the company’s Quality Management System.
The Quality Ops Analyst will be involved in the development, implementation and maintenance of Quality System processes to meet the requirements of US FDA (e.g., 21CFR 820 QSR), ISO 13485), and other applicable quality and regulatory standards.
The Quality Ops Analyst works with relevant departments to ensure successful implementation of quality systems and communicates the impact of changes to areas affected to ensure that the changes are integrated into day to day operations.
The Quality Ops Analyst I coordinates and participates in internal audit activities and key quality initiatives as appropriate.
The Quality Ops Analyst recommends CAPAs and SCARs based on top issues seen from NC activities and supports the compilation of device master records, device history records, training records, CAPA records and other Quality System records.
Responsibilities:
- Perform review of the incoming inspection records completed by IQC inspectors
- Ensure lots meet QC functional test requirements and acceptance criteria; review data provided by supplier, as applicable, prior to material release
- Release approved lots to inventory via the ERP system (SAP)
- Facilitate initiation, review and closure of nonconformance records (NCRs) associated with inspection lots, including evaluation and disposition activities as needed
- Ensure proper handling, quarantine and disposition of discrepant material
- Provide process improvement ideas to improve the incoming inspection process
- Coordinate with Supply Chain to ensure timely deliverables
- Assist in training in GDP and other relevant Quality System training.
- Support Quality system audit activities
- Develop and redline procedures and specification sheets for Quality Inspection
- Collaborate with other Global Illumina sites to align incoming inspection processes
- Perform first article inspection for new product qualification
- Collaborate with LCM engineering to develop value added inspection and acceptance criteria based off criticality
- Review and recommend changes to existing inspection procedures and engineering specifications
- Collaborate with V&V of execution of IQC validation activities
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
- Experience working in a regulated environment in Q.A.
- Working knowledge with domestic and international Quality System Regulation requirements for the In Vitro Diagnostic industry; e.g., 21CFR Part 820, ISO 13485:2003, and/or IVD Directive.
- Must understand risk mitigation in order to evaluate inspection plans
- Knowledgeable in the change control process
- Proficient with MS Office applications, including Visio, Excel and Access.
- Good organizational skills and attention to detail.
- Must have excellent interpersonal skills, writing skills, and communication skills.
- Individual must work well with others, in a positive, collaborative work environment
- Able to identify key issues and drive take initiative to drive toward continuous improvement
- Very detailed and self-motivated. Able to work independently with minimal supervision.
- Solid experience with MRP/ERP databases.
- Must be able to lift up to 35 pounds
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Experience/Education:
- Typically requires a Bachelor’s degree and no previous related experience; or 1-3 years of QC experience.
- ASQ Certification (CQI,CQT, etc) is a plus.
At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and 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 demonstrate our collective commitment to diversity and inclusion in the communities we live and work. 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. 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
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