Laboratory QA specialist

Labcorp is seeking a Laboratory QA specialist to join our team in Shanghai China.

Job Responsibilities:

• Provide guidance to the laboratory operations, Medical Affairs and Scientific operations groups for quality and regulatory related tasks.

• Lead and facilitate quality event (QE) investigations in collaboration with laboratory technical staff ensuring accurate event descriptions, robust root cause analysis (RCA), and development of comprehensive mitigations, including corrective and preventative actions (CAPAs) and defined effectiveness checks.

• Coordinate QEs review and discussions with Quality management Team (QMS) and other impacted groups

• Ensure clear and complete documentation of QE’s in the quality management tool (Veeva)

• Drive timely resolution of audit and QE-related tasks, ensuring all investigations, CAPAs, and associated activities are completed within established regulatory and client timelines.

• Ensure adherence to regulatory requirements and internal Quality Assurance standards as defined in applicable controlled documents, policies and procedures.

• Facilitate and support the controlled document review and revision process, coordinating with document owners and stakeholders to ensure accuracy, completeness, and timely approval.

• Support the laboratories with review and maintenance of training and competency records and matrices.

• Analyze and trend quality event data, including root causes and recurrence patterns; escalate systemic risks and emerging issues to laboratory leadership with actionable recommendations

• Support building and implementing action to mitigate risks.

• Monitor the quality document review dashboard to ensure timely completion.

• Other duties as assigned by management

Minimum Qualifications:

• Bachelor’s Degree

• 4 or more years of experience in a regulated medical laboratory environment

Preferred Qualifications:

• Knowledge of database and data analytics applications.

• Knowledge of medical laboratory regulatory requirements.

• 3 months or more experience with laboratory processes or project management in a laboratory activity environment, working in the medical industry.

• Proficiency in English

Additional Job Standards:

• Problem solving: Dynamic attitude and ability to provide insights on current processes: understand the current situation and processes limitations and provide constructive feedback for improvement. Experience with leading Root Cause Analysis.

• Skilled in concise and accurate. Writing should require little to no external review or editing.

• Creative source to support complex projects and situations and resolve day-to-day problems.

• Decision Making: Ability to analyze situations and guide cross functional teams for problem solving.

• Assess risks of the situation and provide support for day-to-day operations while keeping leadership informed

• Personal Interactions and interpersonal skills: Able to work in a team as well as independently with very little supervision.

• Negotiate best operational solutions to bring the teams and projects forward.

• Demonstrate interpersonal and facilitation skills

• Demonstrate ability to balance many priorities simultaneously

• Able to train and mentor other team members, and connect cross functionally

• Special competencies: Strong organizational skills. Ability to use several software packages i.e. Word, Excel, Power BI,.)

At Labcorp we have a passion for helping people live happy and healthy lives. Every day we provide vital information that helps our clients and patients understand their health. If you are passionate about helping people and have a drive for service, then Labcorp could be a great next career step!

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), 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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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