Clinical Trials Quality Associate II
Quest Diagnostics

Marlborough, Massachusetts

Posted in Health and Safety


This job has expired.

Job Info


Look for more than answers.

At Quest, we are on a continuous journey of discovery and development. It's this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast-moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

Clinical Trials Quality Associate II

This is the intermediate level position in the Quality Assurance track. Demonstrates a working knowledge of regulatory requirements and exercises judgement within defined areas of responsibility. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Is able to perform duties and responsibilities with moderate supervision.

Job Responsibilities:

• Under general supervision, engage in planned and systematic activities to provide confidence that SCT is fulfilling its requirements for quality and continuous quality improvement.

• Perform process-based inspections and conduct audits of laboratory and study records to ensure compliance with regulatory requirements and company standards.

• Review policies and procedures. Recommend revisions to existing policies & procedures, or creation of new procedures.

• Demonstrate and apply knowledge of regulations, GCP, and GCLPs and best practices and help maintain a state of "continual inspection readiness".

Auditing & Inspections:

Under general supervision, conduct audits on a periodic basis according to an established schedule/annual audit plan, including - but not limited to:

o In-process inspections, audits, and data and documentation reviews

o Facility inspections

o Study audits

o Validation and Qualification audits

o QMS audits

o Competency assessment records audits

o Training records audits

• Prepare written audit reports of all activities and report findings to Management and/or Study Director as applicable.

• May assist with development of the annual audit and inspection plans

• Assist with client inspections (e.g. study and facility inspections) including

o Assist with scheduling and coordinating with SCT staff and performing lab staff,

o Advanced preparation and inspection readiness

• May assist with post-audit follow-up to ensure remedial or corrective action resulting from audits is completed within the specified time frame

• Review laboratory procedures and documentation for compliance with SOPs, protocols and applicable regulations.

Participate in the Quality Management Program including, but not limited to:

• May assist with preparation of Annual Quality Plan & Annual report(s).

• Provide assistance with and review of NCEs and CAPAs

• Assist in maintaining and monitoring Quality Assurance specific quality indicators.

• Assist in the prompt and complete reporting of Reportable Quality Issues (RQI)

• Participate in administrative functions of the QAU (e.g. updating records, maintaining spreadsheets, preparation of reports, filing, etc.)

• Assist with Vendor Qualification activities

Document Control:

• Review controlled documents (SOPs, forms, etc.)

• Write, review and/or revise QA SOPs.

To qualify, the ideal candidate will have the following skills and experience:

• Bachelor's degree in a related scientific or technical discipline

• 2-3 years experience in a QA role in a GLP or GCP environment

• Knowledge of GCP and/or GLP, Standard Operating Procedures, and Quality Systems principles.

• Quality Assurance certification; e.g. RQAP-GCP, CQA preferred

• Knowledge and experience in 21 CFR Part 11 preferred

Apply Today

Join us for competitive benefits and development opportunities in a progressive and supportive environment. Help us improve our service, and the experiences of our patients and colleagues. Work with us and together we can be better.

Your Quest Career. Seek it out.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Quest Diagnostics is an Equal Opportunity Employer: Women / Minorities / Veterans / Disabled / Sexual Orientation / Gender Identity.


This job has expired.

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