Coordinator - Assay Validation

2 days ago

Bengaluru, India Labcorp Full time

**I. Job Summary**:
The statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job.

As part of a Global Clinical Pathology Services (CPS) department, provide support to Clinical, Safety Assessment (SA), and standalone studies over a wide range of Clinical Pathology platforms, supporting an enhanced solutions-based approach to Clients’ requests.

As a Coordinator - Assay Validation the job holder will develop their administrative skills and become experienced in their job role, they will become competent, making mínimal errors leading to quality incidents and reduce the input required of other team members. A Coordinator - Assay Validation will display all the behaviors as expected of a Labcorp employee.

The jobholder has specific administrative duties which include working with the assay validation team based at various Labcorp locations.

**Essential Job Duties**:

- To be responsible for table template generation within excel in support of assay validation projects.
- To be responsible for data table entry within excel in support of assay validation projects.
- To be responsible for the QC of data table entry within excel in support of assay validation projects.
- To be aware of the assay validation acceptance criteria and communicate to the Responsible scientist any noted failures.
- To be responsible for table finalization in support of assay validation projects.
- To be responsible for ensuring the draft validation report has the correct tables embedded within word in support of assay validation projects.
- To liaise with the global validation team of any issues with requested turnaround times.
- Review SOPs for the section in support of assay validation projects.
- To be responsible for the updating the Assay Validation SharePoint page with finalized documentation in support of assay validation projects.
- To be trained to assist in the CPS/Global Archiving procedures when required in support of assay validation projects.
- To have a clear understanding of GLP/GCP/SOPs and their implications for CPS validations, and to work in strict accordance with them at all times. Principally this will entail adherence to the relevant Good Laboratory Practice regulations as issued by the UK Medicines and Healthcare Products Regulatory Agency (MHRA); the relevant OECD Principles of Good Laboratory Practice and Compliance Monitoring; and the relevant OECD Guidelines on the Organization and Management of Multi-site Studies.

**II. Experience**:
**Minimum Required**:
Years of experience in the job discipline - Not applicable

Years of experience in other professional roles - Not applicable

Competent with MS Office and MS Excel.

Excellent attention to detail.

Knowledge of GLP/GCP and regulatory requirements is advantageous.

Understanding of CPS processes and procedures is desirable.

An appreciation of what constitutes as excellent customer service is desirable.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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