Due to continuous growth and demand we are hiring a Quality Specialist to work closely with QA Management, internal/external clients and vendors or suppliers of Labcorp.
We're ideally Ideally you will also have experience mentoring and providing error training to colleagues but quality review training can be provided.
As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services, paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
The position will be full time and 100% remote within Bulgaria, Romania or Greece. If you are looking for hybrid working or some office contact, this would be possible for those located near Sofia or Bucharest.
Writing/Reading: English and local language as well as either of the above.
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.
Ensure compliance of operations with governing regulatory requirements.
Perform Quality review of assigned cases.
Assist in compiling quality metrics based on this review and identifying quality trends.
Assist in addressing periodic client quality reviews.
Assist in preparation of Corrective and preventive actions as requested.
Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers.
Assist in the conduct of process review for assigned process and measure and monitor audit readiness.
Assist in designing and tracking training schedule and training material for new hires and existing team.
Contribute to discussion forums on Quality errors within assigned project and help identify process improvements.
Assist in coordinating respective client or external audits of the assigned projects as requested.
Assist in development of Quality Management Plan for assigned project.
Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences.
Relevant safety experience, similar to duties above and ideally experience handling calls/cases.
Any peer review or quality review experience in a contact centre environment would be advantageous.
Knowledge of regulatory requirements and applicable EU and FDA guidelines.
In-depth understanding of case processing and assessment.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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