
Quality Assurance Specialist
2 weeks ago
We are seeking a highly skilled Quality Assurance Specialist to ensure the quality and compliance of advanced wound care products.
Key Responsibilities:- Conduct routine quality checks and inspections on raw materials, in-process materials, and finished products to guarantee adherence to regulatory standards.
- Perform various tests (e.g., sterility, moisture content, tensile strength) on wound care products, documenting results accurately.
- Maintain precise records of QA activities, including inspection results, test data, and non-conformity reports; prepare reports for management and regulatory bodies.
- Evaluate QC procedures to ensure they meet GMP, ISO, and local regulatory standards relevant to wound dressing manufacturing.
- Oversight of calibration and maintenance of QA equipment and instruments to ensure accuracy in testing.
- Cross-functional collaboration with production, R&D, and quality assurance teams to troubleshoot quality issues, provide feedback, and support process improvements.
- Identification of areas for improvement in QA procedures and contribution to implementing enhanced quality systems.
- Bachelor's degree in Chemistry, Pharmacy, or a related field.
- Minimum 2 years of experience in quality control, preferably in a pharmaceutical or medical device manufacturing environment.
- Familiarity with wound care products, sterilization processes (e.g., Electron Beam, Gamma Radiation), and GMP/ISO standards.
- Strong analytical and problem-solving skills, with attention to detail.
- Proficient in quality testing techniques and use of lab equipment.
- Excellent communication and reporting skills.
- Ability to work independently and as part of a team in a fast-paced environment.
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