Quality Assurance Laboratory Specialist
8 hours ago
We are seeking a highly skilled and detail-oriented Quality Control Laboratory Technician to join our team at Compunnel Inc. in Exton, PA. As a key member of our Quality Control team, you will be responsible for conducting laboratory tests and inspections on raw materials, in-process, and finished products.
Key Responsibilities- Conduct laboratory tests and inspections on raw materials, in-process, and finished products.
- Analyze and maintain all test data according to cGMPs.
- Conduct thorough batch record reviews as part of material approval process.
- Initiate NCRs as needed and execute the final disposition, including MRB transactions.
- Organize laboratory supplies and documentation.
- Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.
- Perform routine equipment maintenance and calibration on equipment.
- Conduct routine environmental monitoring on controlled areas and water systems.
- Offer suggestions on improvement of methods and implement through change control process.
- Perform other duties as assigned.
- Adhere to Biomedical Quality System procedures regarding ISO 9001 and/or 13485 standards.
- Associates degree in the biological or chemical sciences. Years of experience may be substituted for degree.
- Minimum 0-3 years of experience demonstrating progressive inspection and testing responsibilities in a laboratory setting.
- Inspection and testing experience within a GMP or ISO 9001 and ISO 13485 environment.
- Knowledge of commonly used concepts, practices, and procedures within a QC environment.
- Basic knowledge & understanding of sampling techniques (ANSI/ASQC Z1.4-2003).
- Must have excellent writing, editing and proofing skills.
- Proficient using MS Word, Excel and Outlook.
The Quality Control Laboratory Technician will work primarily in QC laboratories and manufacturing clean rooms. The technician must follow all safety regulations, including wearing appropriate attire (lab coat, gloves, goggles, mask, respirator, etc.). The technician may be required to work with toxic and/or caustic chemicals, or other hazardous materials.
Education and ExperienceA minimum of 0-3 years of experience in a laboratory setting is required. The ideal candidate will have an associates degree in the biological or chemical sciences, or equivalent experience. The technician must have excellent writing, editing, and proofing skills, as well as proficiency in MS Word, Excel, and Outlook.
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Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Manager
1 day ago
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