IT Applications Analyst-QC Systems
We are currently looking to fill the position of Senior IT Applications Analyst in the Quality Control Systems group. As an Applications Analyst, you will be a vital member of a team responsible for the implementation and support of the Labware LIMS application. A significant focus of this role is ensuring quality and compliance in a highly regulated cGMP environment. The systems we support are crucial in the production of Regeneron’s life-saving products.
As a Senior IT Applications Analyst a typical day might include the following:
- Ensuring the Labware application remains in a compliant state by processing change control requests for system configuration, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments.
- Collaborating closely with laboratory personnel to set priorities and support business-critical projects.
- Initiating, authoring, and reviewing documents such as Change Controls, investigations, deviations, risk assessments, impact statements and corrective/prevention action plans.
- Participating in, leading, or authoring investigations and root cause analysis for department issues of non-compliance.
- Drafting, approving and following relevant system software SOPs and policies
- Representing the team as the Labware LIMS Subject Matter Expert during technical and planning meetings.
- Ensuring system integration with other applications as required (e.g. Waters Nugenesis ELN, Biovia ELN, Oracle OPM, Werum MES).
- Ensuring appropriate user access including control access to software systems; by configuring user roles, user groups and security settings.
- Supporting system validation and qualification efforts.
- Providing leadership including code and configuration reviews, coaching, and assistance to junior team members.
- Building, maintaining, and troubleshooting Labware Visual Workflows and LIMS Basic.
- Enjoy working independently, while at the same time being part of a collaborative, engaged team intent on crafting and delivering quality applications
- Desire to be a key contributor within an organization delivering cutting-edge medicines
- Have an expertise in administration and configuration of Labware LIMS software
- Enjoy the challenge of learning new systems and applications
- Are familiar with regulatory and quality policies, procedures and documentation methods, ideally in cGMP biotech/pharma operations
- Enjoy helping end-users solve problems and are committed to finding innovative solutions to laboratory testing challenges
- Have some project management experience
- Possess stellar organizational skills
- Appreciate the importance of Quality Control in the laboratory and IT settings
Applicants ideally should have a BS/BA in Science, Information Systems or other relevant field and the following 5+ years of experience with Labware LIMS in a GXP industry. Applicants with 2+ years of Labware experience may be considered for IT Applications Analyst; 8+ years for Principal IT Applications Analyst. Experience in a pharmaceutical setting highly preferred. We will consider additional relevant experience in lieu of the educational requirement. Level will be determined based on qualifications relevant to the role.
Remote work (full or part time) may be available to the right candidate.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.