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Quality Assurance Specialist
2 months ago
Englewood Lab, Inc is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities- Regulatory Compliance: Maintain and update regulatory compliance documents, including those of external origin, to ensure adherence to industry standards and regulations.
- Document Control: Manage and maintain document control, including records retention, to ensure accurate and up-to-date documentation.
- Quality Audits: Participate in internal and external audit processes, including mock product recall audits, to identify areas for improvement and ensure compliance.
- Change Control: Effect changes to specification sheets and maintain evidence of product and process changes through approved change control requests.
- Supplier Qualification: Maintain suppliers and vendors qualification program to ensure compliance with industry standards.
- Record Retention: Maintain records retention for the QA department, including Annual Drug Reviews and Device History Reviews.
- Collaboration: Collaborate with cross-functional teams, including EWL Employee training and documentation, to ensure effective communication and implementation of quality initiatives.
- Education: Minimum of 2 years of diploma program or 4-year college degree.
- Experience: 2 to 3 years industry or related experience, preferably in Pharma, Cosmetics, food, medical device, or allied profession.
- Skills: Excellent knowledge of Word, Excel, Access, and other Windows-based programs, good technical writing ability, and good record-keeping skills.
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
