Job Description
Job Description
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.
Job duties:
- 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.
Additional Responsibilities:
- Responsible for neatness of work area plus care and operation of standard office equipment
Qualification/Requirements:
- Experience required in Quality Control inspection
- Bachelor’s Degree or higher with4-6 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