Scientific Affairs and Quality Associate
Asct, Austin, TX, United States
Job Functions, Duties, Responsibilities and Position Qualifications:
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
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.
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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
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.
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