Scientific Affairs and Quality Associate

Job Functions, Duties, Responsibilities and Position Qualifications:

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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.

Key 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

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

Scheduled Weekly Hours:

40

Work Shift:

Job Category:

Laboratory Operations

Company:

Sonic Reference Laboratory, Inc

Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.