QC Key User

Job Title: QC Key User

Location: Swiftwater, PA

The Key User is essential to Quality Operations at the Swiftwater, PA site, serving as a primary resource for the maintenance, improvement, and governance of LIMS database applications and associated equipment supporting the sampling and testing. This role supports Business and Digital LIMS Administrators in creating and updating master data for new and existing products, environmental monitoring (EM) sampling and analyses, maintaining system documentation, and providing ad‑hoc support to other departments.

In addition, the Key User is responsible for the administration and support of the LIMS database applications, ensuring the integrity of environmental monitoring data and alignment of EM programs, procedures, templates, and alarms.

The Key User will bridge business requirements and technical solutions, ensuring that LIMS and EM systems remain aligned with operational, quality, and regulatory standards. The candidate will also interact with health authorities during inspections and must be adaptable to changing priorities in a high‑stress environment.

• LIMS Administration & Maintenance – support master data configuration, data migration, system validation, SOP revisions, and end‑user training.
• Conduct system and process training, and perform system audits covering user access and data accuracy.
• Administer EM database applications, assign EM site locations, manage templates and alert levels, and control particle counters to ensure compliance with the EM program, procedures, templates, sites, and alarms.
• Configure and maintain instrument interfaces to laboratory equipment.
• Manage global system updates and changes, including new modules and workflow changes.
• Develop and manage LIMS improvement projects.
• Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability, and R&D operations.
• Provide first‑level diagnostics of incidents and support business users, Global Digital LIMS Administrator, and Support Center in resolving technical issues.
• Assist the Global Digital LIMS Administrator in creating, validating, and maintaining reports, calculations, and queries.
• Proceed with the master data management process, updating specifications and supporting the approval process.
• Support the business and Global Digital LIMS Administrator in defining, approving, and validating new business requirements.
• Maintain the integrity of EM database applications by identifying and correcting errors, communicating errors to Manufacturing & Supply, and driving corrections through the Data Management Systems request process.
• Ensure that the LIMS complies with all relevant regulatory standards.
• Play a key role in system governance through participation in local, regional, and global governance committees.
• Provide ad‑hoc support to other departments to ensure compliance with all regulatory standards.
• Support audits and inspections by providing data and information on request, including potential direct interaction with health authorities during inspections.
• Create and maintain processes to improve the regulatory review process.

• Bachelor's degree in Computer Science, Life Sciences or related fields.
• Excellent written and verbal communication skills with the ability to lead and participate in cross‑functional teams.

• Experience in the use and administration of a Lab Ware LIMS, including LIMS Basic.
• Prior experience with EM databases, including One Li Ms  and MODA.
• Prior experience with quality applications such as Qualipso.
• Strong working knowledge of laboratory processes, including cGMPs in a pharmaceutical environment.
• Experience in system testing, validation, and master data management.
• Familiarity with 21 CFR Part 11 data integrity best practices in a pharmaceutical environment.
• Prior experience with Microsoft Office, specifically Excel and PowerPoint.
• Experience with complementary laboratory and enterprise systems (e.g., laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, SAP).
• Experience with SQL and database structures.
• Experience in the development and delivery of…