Search Quality Evaluator

Alignerr Corp.; Quilmes; On-site; ARS 600,000 - 900,000; Full time

Job summary

IQVIA Laboratories in Buenos Aires, Argentina is seeking an Operational Quality Specialist to support global laboratory quality and technical systems. You will oversee assay quality control processes, proficiency testing reviews, and manage the scientific database while coordinating with global teams.

The role requires a Bachelor’s in medical technology and at least 3 years in a research or clinical lab, with advanced Excel skills.

Qualifications

• Bachelor's Degree in medical technology or equivalent required
• 3 years experience in a research laboratory/clinical laboratory environment required
• Knowledge of laboratory equipment, clinical laboratory assays, quality control, and validation procedures
• Advanced Excel spreadsheet skills

Responsibilities

• Establish, review, and update global acceptance criteria for harmonized assay quality control materials
• Monitor and review regional laboratory investigations related to proficiency testing failures
• Maintain and update the Scientific Database, including test code system administration
• Monitor global inventory levels of harmonized reagents, calibrators, and quality control materials
• Deliver training to Global Harmonization and regional laboratory teams as needed
• Facilitate and document global technical meetings
• Collaborate with assay development, scientific review, data management, vendor, and laboratory management teams

Skills

Advanced Excel

Education

Bachelor's Degree in medical technology

Job description

Buenos Aires, Argentina

Full time

R

We are seeking Operational Quality Specialist to join IQVIA Laboratories at Buenos Aires, Argentina.

We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development.

Job Summary:

Support and enhance global laboratory quality and technical systems by overseeing assay quality control processes, proficiency testing reviews, scientific database management, and global technical coordination. Collaborate across laboratory, scientific, data management, vendor, and management teams to ensure consistent quality standards and operational excellence.

What You'll Be Doing:

• Establish, review, and update global acceptance criteria for harmonized assay quality control materials


• Monitor and review regional laboratory investigations related to proficiency testing failures


• Maintain and update the Scientific Database, including test code system administration


• Monitor global inventory levels of harmonized reagents, calibrators, and quality control materials


• Deliver training to Global Harmonization and regional laboratory teams as needed


• Facilitate and document global technical meetings


• Collaborate with assay development, scientific review, data management, vendor, and laboratory management teams

What We Are Looking For:

• Bachelor's Degree in medical technology or equivalent required


• 3 years experience in a research laboratory/clinical laboratory environment required


• Knowledge of laboratory equipment, clinical laboratory assays, quality control, and validation procedures


• Advanced Excel spreadsheet skills


• Other Equivalent combination of education, training, and experience may be accepted in lieu of degree

The Knowledge, Skills and Abilities Needed for This Role:

• Knowledge of clinical and/or research laboratory environments, including safety and infection control procedures


• Ability to balance multiple priorities while maintaining quality and accuracy


• Ability to establish and maintain effective working relationships with coworkers, managers, clients, and cross-functional stakeholders

What We Offer You:

We put our employees at the center of everything we do and are committed to providing them, and their families, with benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees' physical, mental and emotional, financial and social well-being so they can thrive at home and at work, at any stage of their well-being journey.

To learn more about our benefits, visit you're looking to unleash your potential, join IQVIA Laboratories to help make the extraordinary possible!

EEO Minorities/Females/Protected Veterans/Disabled

Locations

• Munich, Bavaria, Germany


• Mexico City, Mexico


• Chennai, India


• Quebec, Canada


• Basel, Switzerland


• Warsaw, Poland


• Durham, North Carolina, United States of America


• Barcelona, Spain


• Sofia, Bulgaria


• Madrid, Spain


• Tokyo, Japan


• Bratislava, Slovakia


• Buenos Aires, Argentina


• Athens, Greece


• Beijing, China


• Reading, Berkshire, United Kingdom


• Mumbai, India


• São Paulo, Brazil


• Full time


• R

Job Overview

This role is assigned to designated Delivery Unit(s), country/countries, sponsor(s), business unit(s), and/or specific tasks as defined by the line manager (LM). Contributes to the development and is responsible for the implementation of specific quality improvement initiatives as agreed with the relevant Head(s) of assigned business lines. Provides advice and supports relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions

• The CQM Lead leverages expertise in risk-based quality and study management to drive actions that strengthen & standardize risk-based approach & deliverables via fit-for-purpose business processes/tools.


• Contributes to the development, and supports implementation of the Quality Management Plan within the scope of the assignment this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness in project delivery.


• Cooperate closely with the relevant business lines and other stakeholders, support maintaining focus on quality in project delivery.


• Provides advice and support to teams within the assigned business line on all aspects of Good Clinical Practice (GCP) compliance.


• Works in close cooperation with teams to manage non-compliance, quality issues


• Assist in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs).


• Informs the assigned business line and Quality Assurance of quality issues according to SOPs.


• Works closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.


• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the line manager, as required by the applicable SOPs.


• Acts as the primary contact for Quality Assurance on quality matters - on the level of the assignment, attend meetings/teleconferences.


• Prepares periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.


• Manages staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.


• Upon agreement with the Head of relevant business line: Performs any other reasonable tasks as required by the role.

Qualifications

• Bachelor's or Master's degree in Medical or Life Science (or equivalent industry experience) required, and PhD preferred.


• Expert knowledge of and experience in (minimum of 12 years) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).


• Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.


• Excellent organizational, interpersonal and communication skills.


• Excellent judgement and decision-making skills.


• Demonstrated leadership and line management skills.


• Excellent influencing and negotiation skills.


• Strong computer skills including Microsoft Office applications.


• Excellent problem-solving skills.


• Demonstrated ability to work in a matrix environment.


• Ability to lead and motivate a clinical team also required.


• Ability to travel within the region/country.


• Ability to establish and maintain effective working relationships with co-workers, managers and clients.


• Fluent in English.

EEO Minorities/Females/Protected Veterans/Disabled

Locations

• Munich, Bavaria, Germany


• Mexico City, Mexico


• Chennai, India


• Basel, Switzerland


• Warsaw, Poland


• Kirkland, Quebec, Canada


• Durham, North Carolina, United States of America


• Barcelona, Spain


• Sofia, Bulgaria


• Madrid, Spain


• Tokyo, Japan


• Bratislava, Slovakia


• Buenos Aires, Argentina


• Athens, Greece


• Beijing, China


• Reading, Berkshire, United Kingdom


• Mumbai, India


• São Paulo, Brazil


• Full time


• R

Job Overview

This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.


• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.


• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.


• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.


• Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.).


• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.


• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.


• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.


• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.


• Act as the primary contact for Quality Assurance on quality matters - on the level of the assignment, attend meetings/teleconferences.


• Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.


• Upon agreement with the line manager: Perform any other reasonable tasks as required by the role.

Qualifications

• Expert knowledge of and experience in ( minimum of 8 years ) processes related to clinical trial design, planning, start up, conduct, analysis, and reporting clinical development (principles and concepts as well as regulatory environment).


• Knowledge of National and International Regulations and Drug Development processes.


• Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.


• Excellent problem solving skills.


• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.


• Fluent in English.

EEO Minorities/Females/Protected Veterans/Disabled