Quality Control Spec I

Bio-Rad Laboratories (Singapore) Pte Ltd - MFG; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Bio-Rad Laboratories (Singapore) Pte Ltd - MFG is seeking a Quality Assurance professional to drive product quality improvements, collaborate with production, manufacturing engineering and supplier quality teams, and ensure compliance with ISO 13485 and regulatory requirements.

You will monitor process data, support QC Instrument Test on reagent management, and update procedures to meet delivery commitments.

Qualifications

• Min 3 years of manufacturing quality control in a regulated environment with exposure to QC laboratory process.
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Knowledge of MDSAP and ISO13485 requirements; lead auditor certification preferred.
• Knowledge of Good Laboratory Practice and handling/disposal of bio-hazard materials.
• Statistical tools experience; Lean/Six Sigma Green Belt preferred.
• Self-motivated, result oriented with minimal supervision.

Responsibilities

• Drive resolution for product quality issues by collaborating with production, manufacturing engineering and supplier quality teams.
• Monitor process data and initiate improvements to meet ISO 13485 (MDSAP) and regulatory requirements.
• Support QC Instrument Test on reagent management and procedural updates to meet delivery commitments.
• Initiate supplier/non-conformance review meetings and ensure timely disposition and closure of QNs.
• Monitor QC test yield and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meetings and participate in failure analysis of Customer Returned Instrument.
• Establish QC criteria and provide training to QC Technicians as needed.
• Monitor performance trends and implement improvement initiatives to meet KPI targets.
• Manage the QC laboratory activities and maintain a validated QC laboratory; troubleshoot equipment.
• Participate in Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly/monthly Quality performance reports for management review.

Skills

Problem-solving

Interpersonal skills

Communication

Leadership

Education

Bachelor’s Degree in Chemistry, Bio-Chemistry or Life Science.

Tools

SAP

ERP systems

Job description

You are responsible for driving the resolution for product quality issues through collaboration with production, manufacturing engineering and supplier quality teams. You would monitor process data and initiate improvements to meet organization objectives, ISO 13485 (MDSAP) and applicable regulatory requirements. You will also support QC Instrument Test on reagent management and procedural update to meet delivery commitment.

How You’ll Make an Impact:

• Initiate internal and/or supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield, collaborate with Engineering and Manufacturing to identify and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meeting. Participate in failure analysis of Customer Returned Instrument to verify complaint and identify Product Quality improvement opportunities.
• Establish process Quality Control criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trend. Implement effective improvement initiatives to meet organization KPI targets.
• Manage QC laboratory activities to support production. Maintain a validated QC laboratory including equipment trouble shooting if required. Identify opportunities to improve laboratory practices.
• Participate and review Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly, monthly Quality performance reports for trend analysis and presentation in scheduled Management Review meeting.

What You Bring:

While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

• Bachelor’s Degree in Chemistry, Bio-Chemistry or Life Science.
• Min 3years of manufacturing quality control in a regulated environment with exposure to QC laboratory process is preferred.
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Experience with ERP systems a plus, SAP preferred.
• Knowledge of MDSAP and/or ISO13485 requirements. Preferable lead auditor certified.
• Knowledge of Good Laboratory Practice (GLP). Handling and disposal of Bio-Hazard materials.
• Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
• Possesses excellent problem-solving, interpersonal, communication and leadership skills.
• Must be self-motivated, result oriented with minimal supervision.

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits:

Bio-Rad's biggest asset is ourpeople, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement:

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.