Scientific Affairs and Quality Associate

Sonic Healthcare USA • Austin, TX

19d • Hybrid

About The Position

We're not just a workplace - we're a Great Place to Work certified employer! Proudly certified as a Great Place to Work, we are dedicated to creating a supportive and inclusive environment. At Sonic Healthcare USA, we emphasize teamwork and innovation. Check out our job openings and advance your career with a company that values its team members! Position Summary Sonic Clinical Trials (SCT) is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials. SCT is a wholly owned subsidiary of Sonic Healthcare, one of the world's largest specialist medical diagnostics companies. The position is based within a dynamic team environment at our Sonic Clinical Trials USA office and hybrid working is available upon completion of training.

Requirements

• Tertiary qualifications, as well as previous quality management systems experience, preferably within the pathology laboratory or other highly regulated laboratory environment.
• Experience working with CAP, CLIA, NYSDOH, ISO and strong working knowledge of GCP required
• Experience in a similar level, multi skilled position in a clinical laboratory environment
• Highly developed analytical, problem solving and troubleshooting skills.
• Experience in computer system validation (CSV) in a QA role
• High level of computer literacy (e.g. MS Office suite or equivalent)
• Excellent communication skills, both written and oral (with the ability to influence stakeholders across the business
• Strong interpersonal skills, high attention to detail, initiative, and ability to manage competing priorities and deadlines
• Ability to effectively support local and global teams, reinforcing a consistent quality culture across regions

Responsibilities

• Day to day management of key quality systems including: Non-Conformances and Complaints Management Document, Risk, Audit, and Archive Management Laboratory Quality Control and Validation documents Change Control Vendor Management Training & Compliance
• Scientific Affairs Support local and global quality projects, contributing to the development and maintenance of a strong quality-focused culture across the business.
• Liaise with referral laboratories on test scoping requirements
• Assist with researching new assays/technologies for internalization
• Liaise with Systems team for new analysis database configuration
• Provide input on SOPs, verification plans, and assay documentation
• Coordinate harmonization activities with regional and global laboratories

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed