Lead Information Systems Analyst

2 weeks ago

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

Experic is a premier contract development and manufacturing organization (CDMO) specializing 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 that cater to diverse dosing and packaging formats. Our commitment is to deliver personalized service to our clients, ensuring the successful execution of their pharmaceutical development initiatives.

We aim to cultivate a team culture rooted in trust, integrity, ethical conduct, and compliance, with a steadfast focus on achieving high-quality outcomes. If you thrive in a collaborative environment and are passionate about making a significant impact, you will find a rewarding experience at Experic. We are dedicated to fostering a respectful workplace that promotes open dialogue and continuous improvement. At Experic, you can build a fulfilling career, engage in meaningful work, and pursue professional and personal growth. 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 integrated systems for potential risks, remediation strategies, and enhancements to existing designs and architectures. The specialist will analyze the functionality of current systems and operational processes to develop requirements for new or modified functionalities, implement fixes or upgrades to existing systems, and ensure optimal system performance while meeting all project deadlines. Furthermore, this position will provide training and support for computer hardware and software services to end users.

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 align with 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 challenges, and develop appropriate solutions.
  • Monitor system performance, connectivity, user activity, processes, and backups, and conduct troubleshooting and optimization of systems and infrastructure.
  • Address application-related issues through effective problem-solving and troubleshooting.
  • Create, maintain, and update documentation as necessary.
  • Translate operational use cases into functional requirements and communicate these 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

A 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

  • Proven ability to build relationships and collaborate across organizational boundaries with all technology stakeholders.
  • Strong understanding of system design and architecture.
  • Willingness to learn and actively pursue new skills and knowledge to stay current with evolving technology.
  • Ability to work independently and prioritize risks effectively.
  • Capable of thriving in a fast-paced environment and managing pressure and deadlines.
  • Flexibility to adapt to various situations as needed.
  • Knowledge of systems engineering and administration best practices and tools relevant to the area of support.
  • Skilled in fostering innovation through understanding and communication of IT trends and emerging technologies that can enhance business value.
  • Excellent customer service and stakeholder relationship management skills, with strong business acumen and the ability to communicate effectively with diverse stakeholder groups.
  • Demonstrated experience in a cGxP environment.
  • Familiarity with PRIORITY ERP and ACE QMS systems is advantageous.
  • Ability to work collaboratively in a team setting.
  • Willingness to work overtime as necessary.

Travel Requirements

  • Domestic travel will be required 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.

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