Quality Assurance Manager
16 hours ago
On Line Design, Inc. is seeking a highly skilled Quality Assurance Manager to oversee the company's Quality Assurance program. The successful candidate will be responsible for ensuring compliance with FDA regulations and industry standards, as well as developing and implementing quality control procedures to ensure that all products meet specifications and quality standards.
Key Responsibilities:
- Develop, implement, and maintain the company's Quality Assurance policies, procedures, and programs to ensure compliance with FDA regulations and industry standards.
- Oversee all aspects of the QA program, including product inspections, testing, and documentation, to ensure consistent quality across all products and processes.
- Lead internal and external audits to assess the effectiveness of the QA program and implement corrective actions as necessary.
- Develop and ensure compliance with FDA regulations related to the packaging and re-packaging of drugs, medical devices, and food products with proper documentation, records, and reports.
- Stay current with FDA regulations, act as the primary point of contact, and guidance documents and ensure that all relevant personnel are trained and informed of any updates or changes.
- Oversee the management and maintenance of clean rooms to ensure they meet industry and regulatory standards for drug, medical device, and food packaging.
- Develop and implement clean room protocols, including environmental monitoring, cleaning, and gowning procedures.
- Ensure that all clean room activities are documented and that records are maintained in accordance with regulatory requirements.
- Conduct regular inspections and audits of clean rooms to ensure compliance with internal and external standards.
- Lead the Quality Control (QC) team in the testing and inspection of incoming materials, in-process products, and finished goods.
- Collaborate with production, engineering, and other departments to develop and implement quality control procedures to ensure that all products meet specifications and quality standards.
- Develop and deliver training programs for staff on QA processes, FDA compliance, and clean room protocols, while fostering a culture of continuous improvement and quality excellence.
- Ensure all QA-related documentation, presentations, and reports are accurate, complete, and in compliance with regulatory requirements.
- Identify opportunities for continuous improvement in quality assurance processes, systems, and product quality.
Qualifications:
- Bachelor's degree in a related field (e.g., Quality Assurance, Engineering, Life Sciences) or equivalent experience.
- Minimum of 5 years of experience in a QA management role, preferably in the packaging or manufacturing industry.
- Strong knowledge of FDA regulations, particularly as they relate to drug, medical device, and food packaging.
- Experience managing clean rooms and ensuring compliance with clean room standards.
- Excellent leadership, communication, and problem-solving skills.
- Ability to work effectively in a fast-paced, dynamic environment.
- Strong organizational skills and attention to detail.
- Certification in Quality Management (e.g., ASQ Certified Quality Manager, Certified Quality Auditor) is a plus.
On Line Design, Inc. is an equal opportunity employer and does not discriminate based on age, race, religion, color, sex, national origin, marital status, physical or mental disability, genetics, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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