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Laboratory Quality Assurance Specialist III
2 months ago
Position Title: Quality Lab Associate III
Location: Onsite
Duration: 12+ months
Position Summary:The Quality Lab Associate III is responsible for executing Quality Control assessments in alignment with established procedures. This includes adherence to specifications, testing methodologies, Standard Operating Procedures (SOPs), and relevant Pharmacopoeia requirements while ensuring compliance with current regulatory standards.
Key Responsibilities:- Conduct analyses in accordance with company specifications, testing methods, and SOPs while ensuring compliance with regulations such as cGMP, cGLP, and cGDP.
- Utilize instrumental analysis techniques including HPLC, Atomic Absorption, Flame Photometry, ICP-MS, and Polarimetry.
- Prepare and submit precise and timely reports for all laboratory activities.
- Prepare and standardize laboratory solutions as required.
- Maintain proper laboratory housekeeping in accordance with established protocols and Good Laboratory Practices (GLPs).
- Perform analytical testing and release of raw materials and packaging components as necessary.
- Execute all tasks safely and in compliance with test methods, SOPs, and safety regulations.
- Analyze complaint and stability samples promptly and accurately, reporting any quality concerns to the lab manager.
Language Proficiency: Ability to read and comprehend English and Spanish.
Regulatory Knowledge: Basic understanding of cGMP regulations.
Technical Skills:- Proficient in computer applications such as Word, Excel, and PowerPoint.
- Experience with laboratory data management systems including Empower, Mass Hunter, and LIMS.
- Capability to operate various laboratory testing equipment.
- Willingness to work rotating shifts, weekends, and holidays.
- Adept at interpreting and converting units of measurement.
- Strong mathematical reasoning skills, including basic arithmetic and percentage calculations.
- Ability to follow detailed written procedures and verbal instructions.
- Bachelor's Degree in Chemistry (Required)
- A minimum of 2 years in a professional analytical chemistry role.
There is potential for a temporary to permanent position based on performance.
