Quality Assurance Assistant

ASO, LLC•Groveland, FL

About The Position

The Quality Assurance Assistant supports the Quality Assurance Manager with a wide range of quality-related tasks to help ensure that the overall Quality System requirements and standards are met, including FDA, ISO, OSHA, and other applicable regulatory requirements. The role supports day-to-day Quality Assurance department activities, documentation and records management, compliance reviews, data trending, audit preparation, and quality investigations and programs.

Requirements

Sound understanding of FDA, QSR, and ISO regulations and basic Quality Assurance principles.
Strong attention to detail, organizational skills, precise handwriting, and documentation skills.
Self-motivation, time management, goal orientation, and effective interpersonal skills.
Ability to apply mathematical concepts such as probability and statistical data.
Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Outlook.
Ability to handle multiple projects simultaneously.
Ability to bend, stoop, and lift up to 50 pounds, as necessary.

Nice To Haves

Bachelor’s degree in Biology or a related science; preferred but not required.
Ongoing training or seminars in Quality Assurance or medical devices.
Three or more years of related Quality Assurance experience in a similar environment.
Prior Quality experience in sterilization, Ethylene Oxide (EO), and/or a medical device facility; highly preferred.

Responsibilities

Support day-to-day Quality Assurance department activities to ensure FDA, GMP, and ISO compliance.
Assist team members in using proper GDP.
Maintain customer files and batch record files.
Trend data.
Archive quality documents and dispose of them according to procedure.
Review and prepare Sterilization Batch Records to ensure quality standards and specifications are achieved.
Review cycle data for compliance with customer specifications.
Support the Quality Assurance Manager with complaint handling, investigations, non-conformances, deviations, corrective and preventive actions, and reporting.
Support the Quality Assurance Manager with engineering change notices, FMEAs, equipment qualifications, and monitoring the Calibration program.
Prepare shipments of test samples.
Manage the Biological Indicator tracking program.
Assist with audit preparations and support the Quality Assurance Manager during audits, as needed.
Assist with updates and modifications to ISO/QSR procedures, work instructions, and forms.
Assist with the Product Damage Reports process.
Assist the General Manager, Quality Assurance Manager, and team members with other assigned duties and projects.