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 individual will work as part of the Quality team to support QC Operations. The QC Technician will be performing routine quality activities for outgoing inspection/review of the Batch Record (BR) or Device History Record (DHR) electronically or in hardcopy forms of a semi-finished or finished products and executes the final release for downstream processes or customer shipment. Functional responsibilities include ensuring that product was made according to the procedure and regulatory requirements as well accurate and timely maintenance and review of manufacturing BR/DHR documentation.

Position Responsibilities:

Review and approval of label/cosmetics check on a finished product.

Review and approval of Batch Record (BR) or Device History Record (DHR)

Responsible for the disposition of the inspected/ reviewed semi-finished or finished products in MES and/or SAP system

Review logistic team\xe2\x80\x99s execution on Country Specific Labelling activities and provide disposition for shipment

Documents the executed inspection/ review and timely recording of data in compliance to Quality Systems specification.

Performs the review and closure of Return Material Authorization (RMA) activities

Reports abnormalities detected during the inspection/ review and raise a non-conformance record (NCR) when required.

Generates Certificate of Conformance (CoC) or Certificate of Analysis (CoA) to finished product when required.

Assists to Customer Care Team requests on CoC, CoA, or product label request

Attends team daily meeting and production standup meeting and shares the information or update to the team.

Contributes to the team\xe2\x80\x99s goal on target KPI for Turn-Around-Time and First Pass Yield.

Propose solutions for issues such as alignment within the team or cross-functional or work instruction/procedure revisions.

Highlight within the QC and/or functional team for any issues that will delay the release of a semi-finished or finished products from BR/ DHR review.

Participates in executing validation runs/ process qualifications associated to BR/ DHR review

Evaluates non-conformance record initiated due to operational issue

Generates and sends weekly KPI report for BR/DHR and present in production meeting when needed.

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.

Position Requirements:

Must have a computer skills and competent in Microsoft Office applications (Word, Excel, Powerpoint, Outlook)

Good written and oral communication skills with clarity and accuracy within the QC team and/or cross-functional team when communicating information such as findings during BR/DHR review.

Ability to initiate and facilitate meeting with cross-functional team for BR/DHR review findings.

Ability to read, understand, and follow work instructions or procedures with minimal guidance and executes associated tasks.

Self-starter, self-initiative, organized, and have attention to detail and accuracy

Ability to work well with a team as well as ability to work independently with minimal to zero supervision.

Able to independently manage workload with quality performance without compromising the priority of supporting product release.

Prepares documents for internal or external audit (ISO/ MDSAP/ Customer)

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

Preferred Experience/Education/Skills:

Preferably diploma holder or higher

Minimum 3 to 5 years Quality Role or related work experience preferably in biotech or medical device industry

Knowledge of Quality process is a plus factor including material disposition, change deviations, non-conformance, and CAPA.

Knowledge or experience as auditee in internal or external audits (ISO/ MDSAP/ Customer).

Illumina believes that everyone has the ability to make an impact, and 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