Quality Specialist

Responsible for performing and coordinating a wide variety of activities pertaining to ensuring that quality requirements are maintained in mailing of sample collection devices directly to patients.

• Create and draft specifications and other documentation for direct patient mailings.
• Draft specifications and documentation for components for direct patient mailings.
• Routes documentation for approval in the document control system.
• Review and approve labeling for direct patient mailings.
• Inspects materials according to established procedures.
• Determines and documents disposition of materials (e.g., accept, reject) as they conform to product specifications.
• Performs product and material releases.
• Ensure patient information is handled in a HIPAA compliant manner at all times. § Verify patient information and component availability before mailing is initiated.
• Perform in process inspections of patient mailings.
• Has authority to reject materials.
• Ensures nonconforming materials are handled and documented appropriately according to established procedures.
• Assist with process improvement and validation activities as required.
• Assist with other Quality Assurance or Quality Control activities as required
• Applies knowledge of good manufacturing and good record keeping practices on a daily basis.

• Experience required in Quality Control inspection
• Bachelor’s Degree or higher with 4-6 years related experience preferred
• Experience preferred with GMP production and/or quality management systems in medical device or pharmaceutical organization
• Ability to organize, manage multiple priorities and detail oriented
• Ability to write and follow written procedures
• Computer proficiency, including proficiency in Microsoft Office
• Good communication skills a must