Associate I, Quality Control Lab – AS&T

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Associate I, Quality Control Lab – AS&T, you are responsible for planning and establishing robust and effective laboratory systems and state-of-the-art equipment/technologies to support the product/method lifecycles. You will maintain laboratory compliance standards to be inspection ready and drive a continuous improvement culture to improve the quality and efficiency of QC workflow and processes in our Tuas facilities. In this role, a typical day will include:

Responsibilities

• Subject matter expert (SME) for laboratory testing asset lifecycle and product stability program:
• Manage and maintain laboratory testing asset (LTA) lifecycle, including selection, procurement, qualification, performance review, re-qualification, and retirement of LTA.
• Develop protocols/procedures, execute qualification and implementation of laboratory testing assets and systems, and prepare reports accordingly within project timelines and budget. Coordinate and complete change requests.
• Determine and implement optimal approaches for laboratory equipment calibration, maintenance, and operation. Ensure laboratory infrastructure and equipment function as intended.
• Govern the lifecycle of the stability program. Responsible for protocol & report writing and data trending & analyses. Provide technical expertise pertaining to stability studies and requirements.
• Perform equipment troubleshooting. Investigate underlying causes, technical faults, and issues pertaining to laboratory equipment, method, or practices, and take necessary actions to resolve the problems.
• Lead, manage and execute projects of small to medium scale and complexity.
• Review and assess external standards and/or regulatory requirements pertaining to quality control activities and implement necessary changes to ensure compliance.
• Develop Annual Product Quality Review (APQR) sub-reports and ensure timely submission of sub-reports without overdue.
• Site point of contact for global communities/initiatives pertaining to the stability program and laboratory testing assets.
• Provide guidance, coaching, and training to the team as required. Conduct training for new or changed test procedures, equipment, or systems.
  
  

• General responsibilities:
• Meet quality objectives set by management & comply with Alcon, QMS, and Safety requirements.
• Timely report non-conformance, out-of-specification, out-of-trend, out-of-expectation events. Lead or assist in root cause analyses for product defects and quality lapses and take effective actions to prevent recurrence.
• Timely completion of all compliance activities without overdue, including but not limited to non-conformance investigation, OOS, CAPA, effectiveness check, change request, training, and periodic review.
• Review/approve records/documents. Maintain integrity, accuracy, and completeness of data and records.
• Compile data to support business and performance metrics reporting.
• Support and back up other AS&T projects/activities, including test method lifecycle, stability program, and Laboratory Information Management System (LIMS).
  
  

• Improve quality and efficiency of QC workflows/processes:
• Drive and promote a continuous improvement culture. Challenge current processes, identify improvements, and drive the effort to implement lab system/process while maintaining compliance and reducing human intervention.
  

• Bachelor's Degree in Chemistry, Bioscience, or Microbiology Engineering Related Study.
• Experience with laboratory equipment qualification, maintenance, troubleshooting, and computerized system validation.
• 1-3 years of experience in the pharmaceutical/medical device industry with GMP knowledge.
• Good understanding of the industrial practices and regulatory requirements related to laboratory equipment and computerized systems.
• Experience of working in/with QC laboratory. Understand QC requirements and laboratory processes/workflow.
• Experience in leading or managing projects.
• Experience with managing stability studies, metrology equipment, data analysis, or data analytics is an added advantage.
• Certified greenbelt is an added advantage.
  
  

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.