Quality Systems Consultant (Miami Gardens)
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Salary: $35 - $45 per hour A bit about us: We are seeking an experienced and dynamic Quality Systems Consultants to join our team. This is a unique opportunity to work with a diverse group of professionals committed to ensuring the highest level of quality and compliance in our products and services. You will play a pivotal role in our company by leading the development, implementation, and maintenance of our quality systems. This position is critical to our success, and we are looking for someone who is passionate about quality and is ready to make a significant impact. Why join us?40 hours per week for 3-6 months! Job Details Responsibilities
- Lead and manage the remediation of quality systems, ensuring compliance with 21 CFR 210, 211, and other relevant regulations.
- Identify and remediate gaps in quality systems, including deviation, OOS, change control, supplier qualification, process validation, and equipment validation.
- Drive the closure of outstanding backlog documentation, ensuring that all necessary actions are taken to achieve compliance.
- Collaborate with cross-functional teams to develop and implement SOP harmonization across the organization.
- Manage supplier quality, ensuring that all suppliers meet our high standards of quality and compliance.
- Lead the process validation and equipment validation activities, ensuring that all processes and equipment are validated according to regulatory requirements.
- Drive continuous improvement in quality systems, identifying opportunities for improvement and implementing changes as necessary.
- Minimum of 5+ years of experience in a quality systems role, preferably in a consulting capacity.
- Extensive experience with remediation, including the remediation of quality systems, deviation, OOS, and change control.
- Proven experience with 21 CFR 210, 211, and other relevant regulations.
- Experience with supplier qualification and supplier quality management.
- Experience with process validation and equipment validation.
- Strong knowledge of SOP harmonization.
- Excellent problem-solving skills, with the ability to identify gaps in quality systems and implement effective solutions.
- Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- A commitment to quality and a passion for continuous improvement.
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