QC Tech II - 1st Shift at THERMO FISHER BIOPHARMA SERVICES PTE LTD

, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Laboratory Techniques, Quality Processes, Data Analysis, Scientific Reasoning, Troubleshooting, Communication Skills, Interpersonal Skills, Organizational Skills, Prioritization Skills, cGMP Standards, GLP Standards, Training, Mentoring, Process Improvement, Instrument Management, Sample Preparation

Industry

Biotechnology Research

Description

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Quality Control Technician II is responsible for performing a variety of tasks to ensure the quality and integrity of products and processes within the laboratory. This role involves executing and reporting test results, troubleshooting instruments, and participating in validation processes. QC Technician II will also assist in training new hires and contribute to process improvements within the QC lab environment. Key Responsibilities: Laboratory Operations: Demonstrating 4 I’s (Integrity, Intensity, Innovation, and Involvement) Conducting instrument daily start-ups and maintaining logbooks Proficiency with basic lab techniques such as pipetting and serial dilutions Understanding instrument operations and quality processes (SOPs, Inspection Plans, Test Methods) Sample preparation and QC buffer solutions Managing inventory and bench stocking Performing daily and weekly housekeeping Data entry Testing and Reporting: Conduct tests and accurately report results. Evaluate results and understand the scientific reasoning and rationale behind data generation. Detect quality incidents in the lab and provide effective feedback to drive the progress of Out of Specification (OOS) investigations. Instrument and Process Management: Troubleshoot and resolve instrument issues. Review stability data and ensure compliance with testing documentation per cGMP and GLP standards. Participate in the execution of validation processes with minimal guidance. Training and Development: Assist in cross-training and training new hires. Develop and apply prioritization skills to manage workload effectively. Continue enhancing proficiency in the use and application of moderate lab procedures. Process Improvement: Adopt and apply basic Practical Process Improvement (PPI) principles to enhance the QC lab environment. Contribute to continuous improvement initiatives and support the implementation of best practices. Qualifications: Education: Associate's or Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry) or equivalent experience. Experience: Minimum of 2 years of experience in a Quality Control laboratory or related field. Skills: Strong understanding of laboratory techniques and quality processes. Proficiency in data analysis and scientific reasoning. Ability to troubleshoot and resolve instrument issues. Excellent communication and interpersonal skills. Strong organizational and prioritization skills. Familiarity with cGMP and GLP standards. Demonstrated ability to train and mentor junior staff. Working Conditions: This position may require standing for extended periods and handling hazardous materials. Must be able to work in a laboratory environment with exposure to chemicals and biological materials.

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Responsibilities

The Quality Control Technician II is responsible for ensuring the quality and integrity of products and processes within the laboratory. This includes conducting tests, troubleshooting instruments, and participating in validation processes.