Job Description

JOB SUMMARY

The Specialist l, Quality Technical Systems will serve as a key Quality Assurance (QA) resource, providing technical and administrative support for the site's Quality Management System (QMS) and Learning Management System (LMS). This role will ensure efficient resolution of system-related requests, support laboratory systems, facilitate new employee onboarding and access, and function as a systems administrator for the site. The Specialist l, Quality Technical Systems 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.

Systems Administration & Support

Serve 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 an d learning systems. Support laboratory system QA oversight, including user access management and compliance monitoring.

Quality Assurance Support

Ensure that system processes and access controls meet regulatory and internal compliance requirements. Support QA activities related to electronic system usage, documentation, and reporting. Act as a liaison between QA, IT, and functional departments for system-related matters. QA review and approval of Engineering, Facility, and Validation (EFV) work activities as needed.

Onboarding & Training

Facilitate system setup and access provisioning for new employees as part of onboarding. Provide guidance to employees and managers on navigating QMS and LMS systems. Support training assignments, completions, and troubleshooting within SuccessFactors LMS.

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:


$91,719.00 - $137,579.00
Bora Pharmaceuticals Injectables, 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 Pharmaceuticals Injectables, 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 protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category