QC Informatics Specialist

Pharmaron • Coventry, RI

5d • $80,000 - $120,000 • Onsite

About The Position

Pharmaron is seeking a Computer System Validation/QC Informatics Specialist to support process chemistry and manufacturing activities through the management of laboratory data software platforms and workflows. This role is within the Quality Control & Analytical department, focusing on developing and supporting their requirements and workflows. The specialist will act as a 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 a 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, with manager support.
• 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, including 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 such as NuGensis LMS, SDMS, ELN, Empower 3, and 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
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans)
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree