QC Informatics Specialist (Computer System Validation)

Position: Computer System Validation/QC Informatics Specialist

Salary Range: $80000 - $120000/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 25000 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.

Were proud of the impact we make and just last year we supported 887 discovery projects 1100 CMC programs and 1397 clinical trials across all phases. Our teams are involved in everything from small molecules ADCs biologics and gene therapies and we work with more than 3300 global customers. To learn more visit .

What Youll 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 Were 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 25000 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 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

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.

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Required Experience:

IC