Analytical Quality Lab Specialist III
2 weeks ago
Position Title: Quality Lab Associate III
Company: Fusion Life Sciences
Location: Onsite
Duration: 12+ months
Position Summary:The Quality Lab Associate III is responsible for executing Quality Control assessments in accordance with established procedures. This includes adherence to specifications, testing methodologies, Standard Operating Procedures (SOPs), and regulatory guidelines to ensure timely support for production operations.
Key Responsibilities:- Conduct analyses in compliance with specifications, test methods, and SOPs, while adhering to current regulatory standards (e.g., cGMP, cGLP, cGDP).
- Demonstrate proficiency in instrumental analysis techniques, including but not limited to HPLC, Atomic Absorption, Flame Photometry, ICP-MS, and Polarimetry.
- Generate and submit precise and timely analytical reports for all laboratory activities.
- Prepare and standardize laboratory solutions as required.
- Maintain proper laboratory cleanliness and safety protocols as dictated by established procedures and GLP standards.
- Perform analytical testing and release of raw materials and packaging components as necessary.
- Execute all tasks safely, adhering to test methods, SOPs, and safety regulations.
- Analyze complaint and stability samples promptly and accurately, reporting any quality concerns to the lab manager or designated personnel.
Language Proficiency: Ability to read and comprehend English and Spanish.
Regulatory Knowledge: Basic understanding of cGMP regulations.
Technical Skills:- Proficient in computer applications (Word, Excel, PowerPoint).
- Experience with laboratory data management systems such as Empower, Mass Hunter, LIMS, and Electronic Lab Notebooks.
- Ability to operate various laboratory testing equipment.
- Willingness to work rotating shifts, including weekends and holidays.
- Competence in interpreting and converting units of measurement.
- Strong mathematical skills for calculations and data analysis.
- Ability to follow detailed written and verbal instructions.
- Bachelor's Degree in Chemistry (Required).
- A minimum of 2 years in a professional analytical chemistry role.
This position offers potential for a temporary-to-permanent opportunity based on performance.
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