QC Technician II

Work Schedule: Standard (Mon–Fri)

Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards.

• Cleanroom: No hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.
• Cold Room / Freezers: -22°F / -6°C
• Office and Warehouse
• PPE (Personal Protective Equipment): Some degree required (e.g., safety glasses, gowning, gloves, lab coat, ear plugs, etc.)
• Hazardous/Toxic Materials: Will work with hazardous/toxic materials

Work Location: Singapore, Gul Circle Site

Working Hours: 8:00am to 5:15pm (Monday to Friday)

Job Purpose

Perform incoming material inspections, measurements, and batch record reviews in accordance with established quality systems that meet ISO 13485 and 21 CFR Part 820 requirements.

Responsibilities

Operations

• Perform incoming material inspections to ensure compliance with quality specifications and applicable regulatory requirements, including ISO 13485 and 21 CFR Part 820.
• Review manufacturing batch records and associated documentation with a high level of accuracy and attention to detail to ensure completeness prior to material release and/or batch closure.
• Communicate and coordinate effectively with Manufacturing and Quality Control teams to support timely release of materials.
• Perform environmental monitoring activities, record measurements, and prepare test reports in accordance with established procedures.
• Raise Nonconforming Material Reports (NCMRs) in TrackWise and perform physical segregation and disposition of nonconforming materials in accordance with approved procedures.
• Perform inventory transactions in JDE to support quality inspection and the product release process.

Sustaining

• Maintain an organized filing system for outgoing inspection reports.
• Conduct investigations and trend analyses of material and reagent performance failures; identify root causes and implement appropriate corrective and preventive actions (CAPA).
• Provide feedback and recommendations to improve work processes and operational efficiency.
• Assist the Senior Technician in updating records on the daily Tier meeting Excel board.
• Perform other duties and responsibilities as assigned.

Requirements

Education

• Higher secondary school, diploma, or equivalent required.

Experience

• Minimum of 1 year of work experience in QA or QC, or a related field.
• Experience in a cGMP environment.

Knowledge, Skills, Abilities

• Strong written and verbal communication skills.
• Ability to meet the requirements of the role.
• Ability to work independently and be an effective teammate in a fast-paced environment.
• Keen attention to detail.
• Self-motivated and results-oriented; work well independently; maintain a positive demeanor with a sense of urgency.
• Good analytical abilities.
• Understand ISO requirements.

Benefits

Competitive remuneration, annual incentive plan bonuses, healthcare, and a range of employee benefits. The company offers employment with an innovative, forward-thinking organization, outstanding career and development prospects, and a dynamic company culture centered on integrity, intensity, involvement, and innovation.