Quality Assurance Manager

1 week ago

Cincinnati, Ohio, United States On Line Design, Inc. Full time
Job Title: Quality Assurance Manager

We are seeking a highly skilled Quality Assurance Manager to join our team at On Line Design, Inc. in Cincinnati, OH. As a key member of our organization, you will be responsible for overseeing the Quality Assurance program, ensuring compliance with FDA regulations, and maintaining the highest standards of quality in our packaging and re-packaging operations.

Key Responsibilities:
  • Develop and implement quality 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.
  • Stay current with FDA regulations and ensure that all relevant personnel are trained and informed of any updates or changes.
  • Manage and maintain 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.
  • 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.
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.

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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