Quality & Regulatory Affairs Specialist

Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.

We are currently seeking a Quality & Regulatory Affairs Specialist in Minneapolis, MN. Your day-to-day duties will consist of and may not be limited to:

• Assist senior regulatory staff with the development of regulatory submissions and pre-publishing activities for electronic filings.
• Tracking and drafting annual updates of regulatory filings, amendments, supporting cross-reference requests and maintaining and organized file structure for each product filing.
• Locate and collect documents to support regulatory submissions.
• Compile regulatory filings, reports, and other submissions.
• Perform pre-publishing tasks to ensure timely set up in eCTD format and complete publishing.
• Participate in quality control review activities to support submissions and other documents.
• Perform post submission tasks including organization and archival of regulatory filings and effective maintenance of supporting documents including appendices and supporting correspondence.
• Support customer questions and requests for cross reference letters in a timely manner.
• Provide support regarding change controls which impact regulatory filings.
• Represent regulatory team in multi-functional team discussions or customer audits.

REQUIREMENTS:

• Bachelor's degree required.
• Three to five years of related laboratory or quality assurance experience or related master's degree.
• Experience Computer entry, typing, or electronic document filing skills preferred.

DETAILS:

Location: Minneapolis, MN.

Direct hire

Qualified candidates are encouraged to apply immediately!

Please include a clean copy of your resume, salary expectations, and any references.

• Receive a quality product and quality team's dedication
• Develop effective quality control processes
• Create and monitor quality control procedures
• Create and maintain company quality documentation, such as quality manuals, quality procedures
• Produce production quality reports for management
• Implement the quality system detailed in the quality manual
• Present quality reports to MGMT
• Implement quality systems and equipment to monitor overall quality
• Assure product quality through maintenance of a quality system in accordance with the quality regulations and customer requirements
• Establish standard work and quality procedures
• Propose quality improvements to document control systems
• Maintain quality control objectives and coordinate objectives with production procedures
• Enforce quality standards and represent customer's interest in quality related issues
• Reinforce quality awareness to the management
• Perform quality checks (in-process)
• Ensure that proper quality procedures and work instructions are in effect and that quality technicians adhere to quality policies and procedures
• Establishing product specifications and quality attributes
• Communicate outcomes of quality activities
• Managing all aspects of quality control for all related suppliers
• Inspecting quality of work produced on machines