Project Services Lab Quality Control Analyst

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

RESPONSIBILITIES

• QC of lab specifications and documents up to and including: Laboratory Specifications Document (LSD); Lab Events
• Schedule/Testing Requirements (LES/LTR), Blood Volume Chart, Exclusion/Alerts/Toxicity Charts, Blinding Charts, Sponsor
• Standards, Internal Configuration Specifications (ICS).
• QC of project databases versus lab specification documents.
• Cross functional collaboration to ensure QC reviews reflect current process and quality standards.
• Work with Set-up Managers and Set-up Specialists to resolve problems or quality findings established during the QC review.
• Oversee and facilitate QC timelines with Set-up Managers to ensure client needs are met.
• Work with Set-up Team and Project Services Managers to analyze and identify quality trends and opportunities for individual,
• regional and/or global training needs and process improvements.
• Maintain quality metrics through careful attention to document control and error counting.
• Collaborate with QC counterparts to ensure global consistency in the study set-up process.
• Participate in the training and mentoring of new QC staff and other Project Services staff as required.
• Participate in external and internal audits as required.
• Provide day to day guidance to more junior staff within the QC function and/or Project Services team; may act as a mentor as
• well as assist in the training and development of more junior staff.
• Assignment of QC reviews within the global function to facilitate the timely completion of tasks in line with standard turnaround
• times.
• Assist in the design and completion of reports to track performance against customer objectives and business goals.
• Participate in special assignments including process improvement initiatives
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

EXPERIENCE

• Typically requires 2 - 3 years of prior relevant experience.

KNOWLEDGE

• Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience.

EDUCATION

Bachelor’s Degree in Science related field

ADDITIONAL WORK EXPERIENCE

• 5 years’ of clinical or research industry experience
• 3 year’s Set-up related and/or Project Management experience  or Equivalent combination of education, training and experience

SKILLS & ABILITIES

• Possesses strong technical aptitude Demonstrated computer proficiency with Microsoft Office, IQVIA systems and ELVIS.
• Experience in a regulated environment Possess an understanding of medical and clinical research terminology
• Ability to work within tight timeframes and meet strict deadlines
• Demonstrated ability to work in a fast paced, deadline driven environment.
• Possesses strong product knowledge. Knowledge of Set-up Management processes and terminology. Knowledge of Project Management process and terminology would be beneficial.
• Demonstrated time management and priority setting skills
• Excellent organizational skills and operational skills.
• Strong verbal communication and listening skills Excellent written and verbal communication skills including good command of the English language.
• Ability to build strong customer relationships Ability to establish and maintain effective working relationships with co-workers, managers and key stakeholders.