Principal IT Applications Analyst – QC Operations
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Albany, NY, USA |
| Salary | $77600 – $148400 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- BS/BA degree in Information Technology or related field
- Senior IT Applications Analyst: 5 years of progressive industry/relevant experience or equivalent combination of education and experience
- Principal IT Applications Analyst: 8 years of progressive industry/relevant experience
- Familiar with regulatory and quality policies, procedures, and documentation methods, ideally in cGMP biotech/pharma operations
Responsibilities
- Coordinating across business departments and stakeholders, gathering, and implementing enhancement requests across departments
- Acting as a Technical SME/Lead on initiatives
- Investigates and resolves computer software and hardware issues
- Ensure systems remain in compliant state – Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation, and quality risk assessments
- Initiate, author, review documents such as Change Controls, EOE’s, NOE’s, DNF’s, risk assessments, impact statements and corrective/prevention action plans
- Participate/lead/author investigations and root cause analysis for department issues of non-compliance
- Working with Quality departments to ensure IT Applications are maintained following development life cycle approach
- Configuration management and recipe/method management
- Identify areas for continuous improvement in business processes, administrative procedures, and/or configurations/architecture standards
- Ensuring data is backed up, and tested, or archived to ensure systems can meet defined RTO (Recovery Time Objective) and RPO (Recovery Point Objective)
- Training other IT Applications team members and providing on-the-floor guidance and support to employees
- Prioritizing the day-to-day work assignments for analysts within the IT department to support application troubleshooting activities
- Maintaining up to date training records for self and direct reports
Preferred Qualifications
- Enjoy both collaborating with a team as well as working independently to develop sustainable solutions to complex problems
- Proven focus on customer service and stellar organizational skills
- Strong analytical and organizational skills, as well as excellent written and verbal communication skills
- Degree of ingenuity, creativity, and resourcefulness in an evolving and sometimes ambiguous environment