QC Informatics Specialist (Computer System Validation)

Pharmaron; Coventry (RI); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401(k) with employer match

Paid time off and holidays

Life insurance

Job summary

Pharmaron in Coventry, RI is seeking a Computer System Validation/QC Informatics Specialist to support the Quality Control & Analytical department with laboratory data platforms and workflows.

You will lead GxP qualification activities (IQ/OQ/PQ), coordinate with IT and QA to ensure compliance, provide end-user training, and support audits while maintaining data integrity across laboratory systems.

Qualifications

• MSc or BSc in Chemistry, or Computer Science, or related fields with minimum of 5 years of GxP experience.
• If qualified in chemistry or a related field, then strong IT supporting experience must be demonstrated including data structures, programming, or information systems.
• If qualified in computer science or related field, strong experience in analytical lab support with chemistry terminology and workflows is required.
• Direct experience with laboratory informatics (LIMS) systems.
• Understanding of QMS, ALCOA+, 21 CFR Part 11, and Data Integrity principles.
• Ability to work cross-functionally between IT and scientific teams.
• Knowledge of FDA, EMA, GAMP, ICH guidance related to data integrity.
• Experience managing stepwise implementation and qualification projects.
• Knowledge of pharmaceutical compliance and industry requirements.
• Experience administering NuGenesis LMS, SDMS, and ELN.

Responsibilities

• Lead lab improvement efforts related to laboratory information handling such as custom reports, ELN, LIMS configuration, and data workflows.
• Coordinate with IT to manage GxP software upgrades, installations, and rollouts for business continuity.
• Perform GxP qualification activities (IQ/OQ/PQ) and prepare related documentation.
• Demonstrate expertise with NuGenesis LMS, SDMS, ELN, and other lab systems.
• Provide end-user training for system owners and users.
• Communicate business priorities between end users and IT.
• Build strong relationships with stakeholders and support audits as needed.

Skills

GxP compliance

Cross-functional collaboration

Documentation

Communication

Education

MSc or BSc in Chemistry or Computer Science

Tools

LIMS

NuGenesis LMS

SDMS

ELN

Job description

Position: Computer System Validation/QC Informatics Specialist

Salary Range: $80,000 - $120,000/yr.

Location: Coventry, RI (On-site)

About Pharmaron

Pharmaron is a global contract research and manufacturing organization (CRO/CDMO) helping pharma and biotech companies bring new therapies to life. With over 25,000 employees worldwide across 28 locations in the US, UK, China, and Singapore, we support drug discovery through to manufacturing with fully integrated high-quality services.

We're proud of the impact we make and just last year, we supported 887 discovery projects, 1,100+ CMC programs, and 1,397 clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,300 global customers. To learn more, visit www.pharmaron.com.

What You'll Do

To support process chemistry and manufacturing activities through management of laboratory data software platforms and workflows. This role is positioned within the Quality Control & Analytical department to develop and support their requirements and workflows and to act as liaison with IT and QA to minimize downtime, improve effectiveness and maintain compliance related to laboratory data generation, storage, and use.

Key Responsibilities

• With the support of the reporting manager in the Quality Control & Analytical department, lead laboratory improvement efforts related to laboratory information handling such as custom report generation, ELN, LIMS system configuration, data storage/organization, and pharmaceutical data workflows.
• Liaising with appropriate technical and IT stakeholders to manage GxP software upgrades, installations, and roll outs to ensure business continuity and effectiveness are maintained and improved.
• Author, review, and perform GxP qualification activities related to QCA as part of the Computer System Validation (CSV) life cycle e.g. GxP Risk & Impact Assessments, URS/FS, Qualification Plan, IQ, OQ, PQ, Requirement Tractability Matrix, Quality Summary Report, periodic reviews and decommissioning activities.
• Demonstrating expertise in site-wide, complex software platforms e.g. NuGensis LMS, SDMS, ELN, Empower 3 etc. as well as various other standalone laboratory system software used within QCA and Process Chemistry.
• Support System Owners within business functions with training end users in the use of the system.
• Liaise between end users and IT to clearly communicate business priorities and ensure that appropriate resources are used to maintain ongoing business operations.
• Build effective business relationships with all stakeholders.
• Support departmental or site audits as directed by manager/supervisor as necessary.

What We're Looking For

• MSc or BSc in Chemistry, or Computer Science, or related fields with minimum of 5 years of GxP experience.
• If qualified in chemistry or a related field, then strong experience in an IT supporting role must be demonstrated including a basic understanding of data structures, programming, and/or information systems.

If qualified in computer science or a related field, then strong experience in an analytical laboratory supporting role must be demonstrated including a basic understanding of common chemistry terminology, application, and laboratory workflows.

• Direct experience with laboratory informatics (LIMS) systems.
• Understanding of common GxP topics including QMS, ALCOA+, 21 CFR Part 11, and Data Integrity principles.
• Evidence of ability to effectively work cross-functionally between IT and scientific teams.
• Working knowledge of applicable FDA, EMA, GAMP, and/or ICH guidance as it relates to data integrity.
• Evidence of ability to manage stepwise implementation and qualification projects.
• Good knowledge on pharmaceutical compliance and latest industry requirements.
• Functional experience in the technical administration of complex laboratory informatics software platforms such as NuGenesis LMS, SDMS and ELN.
• Effective written and oral communication skills, including the ability to effectively present complex information to colleagues.
• Effective in managing multiple competing activities and delivering to timelines.
• Ability to work professionally in a cross-functional environment and clearly reinterpret/translate concepts across IT and Laboratory staff.

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 25,000 employees and operations in the US, UK, China, and Singapore. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

As an Equal Employment Opportunity and Aff. Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Aff. Action employer.