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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Technician to join our team at Kellton Tech. The successful candidate will be responsible for ensuring the quality of our products and processes, and will work closely with our manufacturing and laboratory teams to achieve this goal.
Key Responsibilities- Perform area clearances and in-process inspections to ensure compliance with regulatory requirements.
- Monitor manufacturing process performance and ensure that components, products, or equipment under evaluation or not in compliance are properly controlled.
- Prepare and attach material quality status on materials, including labeling.
- Verify all labels after final printing is completed.
- Execute assigned activities in accordance with production schedule and participate in production schedule planning, as needed.
- Assist in the development, implementation, and maintenance of site quality procedures, standards, and controls.
- Support the quality audit function through occasional conduct of investigations of nonconformances or deviations and assist with corrective actions and preventative actions associated with site quality.
- Perform other tasks related to the assurance that product meets established standards for quality and efficacy as assigned by supervisor.
- Associate's Degree in a technical or scientific related field required.
- Bachelor's Degree (preferably in a science related field) preferred.
- Experience in a regulated work environment is preferred.
- Quality certificate preferred (ASQ CQE, CQA, etc.).
- Understand and internalize drug cGMPs, OSHA, EPA, and FDA regulations/requirements as related to drug and medical device manufacturing.
- Proficient in Word and Excel.
- Mathematical skills.
- Mechanical aptitude.
- Excellent oral and written communication skills; interpersonal skills; and organizational skills.
- Detailed-oriented.
- Excellent team ethic and practice.
- Collaborative, tactful, and able to communicate with various levels in the organization.
- Assertive in enforcing regulations, policies, and procedures.
- Basic knowledge of laboratory analyzers and inspection equipment used to perform chemical analyses and component inspections.