QC Technician II

JOB DESCRIPTION

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... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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 to established quality systems that meet ISO13485 and 21-CFR-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 the timely release of the 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 the 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 related field

• Experience in a cGMP environment

Knowledge, Skills, Abilities:

• Strong written and verbal skills

• Can demonstrate an ability to meet the requirement

• Can work independently and be an effective teammate in a fast-paced environment

• Requires keen attention to details

• Must be self-motivated, results-oriented, work wrll independently, and have a positive working demeanor with a matter of exigency

• Good analytical abilities

• Understand the ISO requirements.

Physical Requirements / Work Environment:

Each one of our 70,000 outstanding minds has a remarkable story to tell.

Join us and supply our unusual mission.

Benefits:

We offer competitive remuneration, annual incentive plan bonuses, healthcare, and a range of employee benefits. The company offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer a dynamic company culture that stands for integrity, intensity, involvement, and innovation!