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QC Informatics Specialist (Computer System Validation) Pharmaron - 2.5 Coventry, RI Job Details Full-time $80,000 - $120,000 a year 1 day ago Benefits Health savings account AD&D insurance Paid holidays Disability insurance Health insurance 401(k) Flexible spending account Paid time off Employee assistance program 401(k) matching Opportunities for advancement Life insurance Qualifications Data integrity assurance Empower (software) Pharmaceutical regulatory compliance Data structures Software implementation Laboratory experience

FDA 21 CFR

Part 11 Software administration Data quality management Technical solutions implementation Managing projects Systems & applications support Laboratory information systems (LIS) Cross-functional collaboration Cross-functional communication

Full 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 ControlAnalytical 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 ControlAnalytical 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 RiskImpact 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:

As part of our commitment to your well-being, we offer a comprehensive benefits package: Comprehensive Medical, DentalVision Insurance with significant employer contributions 401(k) Retirement Plan with generous employer matching Generous Paid Time Off (PTO), Paid Sick LeaveCompany Holidays to support work-life balance Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus HealthcareDependent 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

How to

Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today! As an Equal Employment Opportunity and Affirmative 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. #LI-KS1