Position Summary:
This position is responsible for Quality activities that improve, monitor and measure Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.
It includes a wide range of activities related to process improvement, ensuring all work is completed accurately within specified time frames, and making sure high levels of customer service are provided at all times. At the direction of the QC Ops Manager, coordinate and execute all aspects of QC operational activities and improvements. These individuals will provide technical leadership to ensure timely delivery of QC activities.
Responsibilities:
Assist to supervise a team of Quality Technicians, provide day-to-day management and support of the QC activities. This includes training, coaching to technicians and compliant to procedures/protocols.
Establishment of On-The-Job Training (OJT) for QC processes.
Identify and implement activities to improve Turn-around-time (TAT) operational excellence and First Pass Yield (FPY) within QC and alignment across departments.
Revising and updating Standard Operating Procedures, system or processes to improve compliance, efficiency and execution.
Assignment may include but not limited to overseeing processes such as non-conformance material, incoming and outgoing inspection, return material authorization, calibration, analytical or bio-molecular QC assays to support release, characterization and stability testing of raw materials, production intermediates and final goods etc.
Assist in developing procedures, work instructions, guidance, best practice protocol such as checklists and troubleshooting guidelines.
Assist in conducting and documenting investigations for OOS results and other discrepancies. May perform troubleshooting on discrepancy observed in laboratory or material as necessary.
Assist in functional testing and qualification run for new/modified product/method equipment and engineering studies if required.
Able to use laboratory information management system (LIMS)
Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.
Ensure that the processes are compliant with Quality System and EHS requirements.
Other such duties that may be determined by Management.
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:
Ability to apply experience in meeting requirement of FDA Quality System Regulations and/ or ISO 13485 Standard.
Experience in applying appropriate quality tools.
Intermediate to advanced experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.
Must be detailed oriented, well organized and able to work independently and in teams.
Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work
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:
Bachelor’s degree in Engineering or Biological/Life Sciences.
More than 3 years of working experience in manufacturing and laboratory environment.
Experience in supporting manufacturing operations, or QC/QA operations.
Have experience in a supervisory role (supervising technicians and /or quality inspectors) is preferred.
Have experience in Laboratory Information Management System (LIMS) is preferred for traceability, chain of custody for QC test samples and data analysis.
Good understanding of FDA regulatory environment (CFR 820), 501k and ISO 13485 strongly preferred.
Experience in medical device/ pharmaceutical/ IVD is preferred.
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.
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