Associate Quality Assurance Specialist

Overview:
Ready to shape the future of science and global health? ATCC, a pioneer in biomaterials manufacturing, is seeking an Associate Quality Assurance Specialist to support quality in the repository for Gaithersburg, MD.
Embark on a career where you’ll be instrumental in upholding quality processes and standards across manufacturing, production, and customer service. Join our dynamic team and contribute to our commitment to excellence and continuous improvement.

Responsibilities:

• Compliance Monitoring and Assurance: Ensure organizational adherence to established Quality Assurance processes and standards across manufacturing, production, and customer service operations, facilitating ongoing monitoring and conformance to enhance overall quality performance.
• Internal Controls and Risk Management: Support the evaluation of internal controls, risk management practices, and documentation maintenance, including Standard Operating Procedures (SOPs), to assess compliance with safety, quality, and regulatory standards, ensuring a robust framework for operational excellence.
• Audit Support and Remediation: Provide invaluable support for internal and vendor audits, identifying nonconformities and assisting in the development of effective corrective actions and preventive measures. Collaborate with departments to mitigate risks, foster compliance, and drive continuous improvement efforts.

Qualifications:

• Bachelor’s degree and 0-2 years’ experience or equivalent experience.
• Previous experience working in a Quality Assurance or compliance-related role, preferably within manufacturing, production, or regulated industries preferred.
• Familiarity with regulatory standards such as ISO 9001, FDA regulations, or other industry-specific quality management systems preferred.
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent communication and interpersonal skills.
• Proficiency in using Microsoft Office Suite and document control software.
• Exposure to Quality Assurance principles, methodologies, and best practices.
• Ability to interpret and apply regulatory requirements and standards effectively.
• Strong organizational skills to manage multiple tasks and priorities efficiently.
• Proficiency in conducting inspections, audits, root cause analysis and developing corrective action plans.
• Excellent written and verbal communication skills for preparing reports, documenting procedures, and facilitating training sessions.
• Detail-oriented approach to document management, including writing, formatting, and maintaining SOPs and other controlled documents.
• Problem-solving skills to identify nonconformities, assess risks, and develop preventive actions.

Benefits:

• Compliance Monitoring and Assurance: Ensure organizational adherence to established Quality Assurance processes and standards across manufacturing, production, and customer service operations, facilitating ongoing monitoring and conformance to enhance overall quality performance.
• Internal Controls and Risk Management: Support the evaluation of internal controls, risk management practices, and documentation maintenance, including Standard Operating Procedures (SOPs), to assess compliance with safety, quality, and regulatory standards, ensuring a robust framework for operational excellence.
• Audit Support and Remediation: Provide invaluable support for internal and vendor audits, identifying nonconformities and assisting in the development of effective corrective actions and preventive measures. Collaborate with departments to mitigate risks, foster compliance, and drive continuous improvement efforts