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Lead Information Systems Analyst

2 months ago

Cranbury, New Jersey, United States Experic Full time
Job Overview

Experic is a premier contract development and manufacturing organization (CDMO) that specializes in clinical trial supply services. Our mission is to provide innovative and scalable solutions throughout every stage of a product's life cycle, from clinical trials to commercial production. We pride ourselves on our advanced pharmaceutical manufacturing capabilities, packaging, and labeling technologies, which cater to a wide range of dosing and packaging formats. Our commitment is to deliver personalized service to our clients, ensuring the seamless and successful execution of their pharmaceutical development initiatives.

We aim to cultivate a team-oriented culture grounded in trust, integrity, ethical practices, and compliance, with a steadfast focus on achieving high-quality outcomes. If you appreciate a collaborative work atmosphere and are motivated by the chance to make a significant impact, we invite you to Experience the Experic difference. We are dedicated to fostering a respectful and equitable workplace that promotes open dialogue and continuous improvement. At Experic, you can embark on a rewarding career, engage in meaningful work, and advance both professionally and personally. A successful candidate will contribute their unique insights, expertise, and methodologies while aligning with our core values.

Position Summary

The Senior Information Systems Specialist will leverage their expertise in operations and production systems to ensure compliant management of Validated Systems within the Experic manufacturing and research environment. This role involves assessing validated hardware, software, and hybrid systems for potential risks, remediation strategies, and enhancements to existing designs and architectures. The Specialist will evaluate the performance of current systems and operational processes to define requirements for the development of new or modified functionalities, implement fixes or upgrades to existing systems and software, and ensure optimal system performance while meeting all project timelines. Furthermore, this position will provide training and support for end users regarding computer hardware and software services.

Key Responsibilities
  • Assess and document the existing IT architecture, workflows, and capabilities to identify necessary adjustments for compliance with cGxPs.
  • Implement optimized and new workflows for critical systems, including integrations that satisfy Experic's business and regulatory standards.
  • Oversee system installation, configuration, user acceptance testing, performance tuning, maintenance, and audit support for validated systems.
  • Ensure quality and regulatory compliance for future software development to maintain adherence to cGxPs.
  • Continuously evaluate, analyze, and communicate system requirements while maintaining systems processes.
  • Operate computer and peripheral equipment and software applications; gather accurate information from users to identify their needs and issues, and develop appropriate solutions.
  • Monitor system performance, connectivity, user activity, processes, and backups, while performing troubleshooting and optimization of systems and infrastructure.
  • Handle application-related problem-solving and troubleshooting tasks.
  • Create, maintain, and update relevant documentation.
  • Generate functional requirements based on operational use cases and effectively communicate those requirements to system vendors.
  • Ensure ongoing compliance with information security policies, processes, standards, and guidelines, as well as regulations from external governing bodies, such as GDPR, 21CFR part 11 (E-Signatures), Annex 11, Annex 15, and HIPAA.
Qualifications

Minimum of five (5) years of experience in information systems within the pharmaceutical industry or a federally regulated business environment is required.

A Bachelor's degree in information systems, Computer Science, Engineering, or a related field is preferred.

Experience in project management is also preferred.

Additional Skills and Abilities
  • Ability to build relationships and collaborate across organizational boundaries by effectively communicating with all technology stakeholders.
  • Understanding of system design and architecture.
  • Willingness to learn and actively pursue new skills and knowledge to stay current with evolving technology.
  • Capacity to work independently and prioritize risks effectively.
  • Adept at functioning in a fast-paced environment and managing pressure and deadlines.
  • Flexibility to adapt to varying situations.
  • Knowledge of systems engineering and administration best practices and tools relevant to the area of support.
  • Skilled in fostering innovation through understanding and communicating IT trends and emerging technologies that can add business value.
  • Exceptional customer service and stakeholder relationship management skills, including strong business acumen and the ability to communicate with diverse stakeholder groups.
  • Demonstrated experience in a cGxP environment.
  • Familiarity with PRIORITY ERP and ACE QMS systems.
  • Ability to work collaboratively in a team setting.
  • Willingness to work overtime as necessary.
Travel Requirements

Domestic travel may be required, but will be less than 10% of the time.

Experic is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.