Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Clinical Laboratory, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer Relations, Customer Support/Service, Document Control, Document Management, Environmental Sciences, ISO (International Organization for Standardization), Insurance Regulations, Labware, Maintain Compliance, Manufacturing, Manufacturing Requirements, Medical Equipment, Process Improvement, Quality Assurance, Quality Management, Quality Metrics, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Risk Analysis, Root Cause Analysis, Systems Maintenance
The Quality & Regulatory Specialist supports quality assurance and regulatory compliance activities for laboratory glassware, packaging, and life sciences products. This role is responsible for maintaining quality systems, supporting audits and certifications, managing documentation, ensuring compliance with applicable regulatory requirements, and driving continuous improvement initiatives.
Client Details
My client is a global leader in precision labware, scientific glass, and life sciences packaging. With a legacy spanning over 100 years, they are committed to enabling scientific discovery and innovation through high-quality products, robust quality systems, and customer-focused solutions.
Description
The key responsibilities of the Quality & Regulatory Specialist will be:
- Support the maintenance and continuous improvement of the Quality Management System (QMS).
- Ensure compliance with applicable quality, regulatory, and industry standards, including ISO requirements and Good Manufacturing Practices (GMP), as applicable.
- Review, create, and maintain quality and regulatory documentation, including procedures, work instructions, specifications, and records.
- Coordinate document control activities and ensure accurate record retention.
- Assist with internal, customer, and third-party audits, including preparation, execution, and follow-up of corrective actions.
- Investigate quality issues, nonconformances, complaints, and deviations; support root cause analysis and corrective/preventive action (CAPA) implementation.
- Monitor quality metrics and prepare reports to support management review and continuous improvement efforts.
- Review change controls and assess potential quality and regulatory impacts.
- Support supplier qualification activities and participate in supplier quality evaluations.
- Assist with product certifications, declarations of conformity, and customer regulatory inquiries.
- Collaborate with Manufacturing, Engineering, Operations, and Customer Service teams to resolve quality and compliance-related issues.
- Participate in risk assessments and validation activities as required.
- Stay current with evolving regulatory requirements and industry best practices.
If interested, please apply using the link below. Qualified applicants will be contacted 24-48 hours upon submittal.
Profile
The successful Quality & Regulatory Specialist will have:
- Bachelor's degree in Quality Assurance, Chemistry, Biology, Engineering, Regulatory Affairs, or a related scientific discipline. Relevant work experience will also be considered.
- 1-5 years of experience in quality assurance, regulatory affairs, manufacturing quality, or a related role.
- Knowledge of Quality Management Systems and relevant ISO standards.
- Experience with CAPA, root cause analysis, audits, and document control processes.
- Strong understanding of regulatory compliance requirements within manufacturing, laboratory, medical device, pharmaceutical, or life sciences environments.
Job Offer
My client can offer the following for the Quality & Regulatory Specialist:
- Competitive Base Salary
- Excellent Benefits
- 401k Company Matching Program
- Growth potential within the organization
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.