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Laboratory Quality Assurance Analyst
2 months ago
Position: Quality Control Analyst
Company: DivIHN Integration Inc
Location: Not specified
Duration: Not specified
Position Summary:
The Quality Control Analyst is responsible for executing Quality Control assessments in accordance with established Client protocols. This includes adherence to Specifications, Test Methods, Standard Operating Procedures (SOPs), and relevant Pharmacopoeia requirements, ensuring compliance with current Regulatory standards to support production activities.
Key Responsibilities:
- Conduct analyses following Client Specifications, Test Methods, and SOPs while ensuring compliance with regulations such as cGMP, cGLP, and cGDP.
- Perform instrumental analyses utilizing at least three of the following techniques: HPLC, Atomic Absorption, Flame Photometry, ICP-MS, and Polarimetry.
- Prepare and submit detailed and timely reports for all laboratory activities.
- Prepare and standardize laboratory solutions as required.
- Maintain proper laboratory housekeeping in accordance with established procedures and Good Laboratory Practices (GLPs).
- Execute analytical testing and release of raw materials and packaging components as necessary.
Compliance and Safety:
- Adhere to all safety protocols, including Test Methods, SOP requirements, and Federal and state regulations (OSHA, EPA, FDA, etc.).
- Timely analysis of complaint and stability samples, reporting any quality concerns to the lab Manager or designated personnel.
- Ensure analytical results are accurate and well-documented.
Qualifications:
- Basic knowledge of cGMP regulations.
- Proficient in computer applications (Word, Excel, PowerPoint).
- Experience with laboratory data management systems such as Empower, Mass Hunter, and LIMS.
- Ability to operate various laboratory testing equipment.
- Willingness to work rotating shifts, weekends, and holidays.
- Capable of interpreting and converting measurement units.
- Strong mathematical skills for calculations and data analysis.
- Ability to follow detailed written and verbal instructions.
- Potential for a temp-to-hire opportunity based on performance.
Education and Experience:
- Bachelor's Degree in Chemistry is required.
- A minimum of two years of experience in a professional analytical chemistry role.
Language Skills:
- Ability to read and comprehend English and Spanish.
About DivIHN:
DivIHN Integration Inc. specializes in providing Professional Consulting, Custom Projects, and Resource Augmentation services to clients across various sectors. The organization emphasizes Standardization, Specialization, and Collaboration in its operations.
DivIHN is committed to equal opportunity employment and does not discriminate against any employee or qualified applicant based on race, color, religion, gender, age, national origin, disability, marital status, sexual orientation, or military status.
