Computer System Validation/QC Informatics Specialist

Pharmaron • Coventry, RI

3d • Onsite

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.
• Liaise 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.
• Demonstrate 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level