Specialist I, Quality Technical Systems-Baltimore

JOB SUMMARY

The Quality Technical Systems (QTS) Specialist provides support for all administrative functions involving the Laboratory Information Management System (LIMS) including system configuration, troubleshooting issues, user access, reporting, authoring SOP's, and ensuring cGMP compliance in the business processes.The QTS Specialist must understand database structure, auditing functions, report query configuration, as well as facilitate and support improvements to the business processes using electronic systems. They will also serve as an administrative resource, providing technical and administrative support for the site's Quality Management System (QMS) and Learning Management System (LMS). The specialist will play a critical role in maintaining compliance and ensuring that personnel and system needs are met in a timely manner.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Quality Assurance Systems Administration & Support

• Diagnose system problems and develop/coordinate resolutions.
• Work Closely with QC, QA, IT, CSV and other functional business units and users to generate user requirements and understand system functionality and use, as well as assist in implementation of new functionality.
• Design of new functionality and overall system improvements.
• Perform administrative activities for the LIMS software including (but not limited to):
• User account administration
• System configuration
• Change Request administration
• Report generation
• Data export
• Database management / validation
• System troubleshooting
• Reviews computer system validation documentation for new and current laboratory and enterprise computerized systems and the modification and re-validation of existing said systems on the site.
• Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols).
• Author and collaborate on SOPs, Deviations, CAPA's and Change Controls as necessary.
• Support QMS as system administrator for Veeva QMS and SAP SuccessFactors LMS:
• Triage and process service tickets in HALO related to QMS and LMS requests, ensuring timely and compliant resolution.
• Manage user accounts, role assignments, and access rights across quality and learning systems.
• QA review and approval of Engineering, Facility, and Validation (EFV) work activities as needed.

Continuous Improvement

• Identify opportunities to streamline workflows, improve ticket resolution efficiency, and enhance user experience.

• Participate in projects to implement, upgrade, or optimize quality and learning systems.
• Develop and maintain system documentation, job aids, and training materials.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:

• Bachelor's degree in Life Sciences, Information Systems, or a related field (or equivalent work experience).

Experience:

• Prior experience administering Veeva Quality Management System and SAP, SuccessFactors LMS required.

• Hands-on experience with ticketing/IT service management tools (HALO preferred).
• Experience in a regulated industry (pharmaceutical, biotech, or medical device) strongly preferred.

Skills & Competencies:

• Strong technical troubleshooting and problem-solving skills.
• Understanding of QA principles, GxP compliance, and data integrity requirements.
• Ability to manage multiple priorities in a fast-paced, compliance-driven environment.
• Excellent communication and interpersonal skills, with the ability to support cross-functional teams.

Compensation Range:

Bora PharmaceuticalsInjectables, Inc.is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment,Bora PharmaceuticalsInjectables, Inc.will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protectedveteran,genetic information, atypical hereditary cellular or blood trait, or any other protected category