- 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.
BenefitsWe Invest in You
- Health & Wellness:
- Comprehensive medical coverage and company paid Life Insurance, Disability Insurance & AD&D
- Work life balance with Paid Holidays and PTO
- Fitness and cell phone subsidies, and additional benefits such as Aflac, legal services, and pet insurance
- Employee Assistance Program offering around-the-clock counseling
- Financial security:
- 401(a) (6% employer contribution) and 403(b) (2% match) retirement plans
- Exceptional career advancement opportunities, recognition, and rewards
- Corporate bonus program
- Mission Focused:
- Non-profit organization supporting critical life science research
- We give scientists the tools they need to make discoveries that improve and save lives
- Contribute to community involvement and social responsibility Join ATCC, where we fuel your success, well-being, and development. We're a mission focused non-profit Equal Opportunity Employer, championing diversity and inclusivity. When you work at ATCC, you become a part of that mission, one we've committed to for almost 100 years. Shape the future of science with us. ATCC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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Associate Quality Assurance Specialist - Gaithersburg, United States - ATCC
Description
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. This Associate Quality Assurance Specialist role is based in a repository setting and is a great entry level opportunity for a recent college graduate with interest in life sciences.
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