Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra? Because we:
Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.
The role:
The Learning Systems Specialist is responsible for the day-to-day operation and support of the organization’s learning management platforms across GxP and non-GxP learning environments. This role ensures accurate system configuration, reporting, and data integrity, while maintaining inspection‐ready training records with global LMS standards, GxP and Non-GxP training compliance requirements. The Learning Systems Specialist supports training Compliance execution by maintaining system functionality, user access, reporting, and data integrity, but does not own training compliance decisions, regulatory interpretations, or site level audit responses. This role works closely with the Global LMS System Owners. The Global LMS System Owner retains accountability for system validation, configuration standards, and change control.
The responsibilities:
LMS Platform Operations & Support
- Manages the daily operation of multiple enterprise learning management platforms and determines operational priorities within the role’s assigned scope. Evaluates business and learning requirements and determines the appropriate platform configuration within approved standards, including learner profiles, access, permissions, curricula, learning assignments, and reporting structures. Owns the accuracy and ongoing maintenance of platform setup for curricula, learning paths, training matrices, recurring requirements, and role-based assignments within approved parameters. Assesses the operational impact and priority of platform issues, enhancements, upgrades, integrations, testing, releases, and change requests and provides recommendations to designated system owners and stakeholders.
Data Integrity & Access Control
- Maintains LMS data integrity, audit trails, and system records in accordance with GxP and data integrity principles.
- Analyzes data quality issues, discrepancies, duplicate records, interface errors, and assignment exceptions; determines root causes and appropriate corrective actions within scope; and escalates material risks through defined channels.
Reporting, Dashboards & Inspection Support
- Determines reporting and dashboard approaches, develops and maintains outputs, analyzes results, and communicates material trends, risks, and recommendations to support compliance monitoring, operational oversight, management review, and business decision-making. Generates and analyzes training compliance reports and supports retrieval and presentation of training evidence during internal audits and regulatory inspections.
- Explains LMS functionality, workflows, and approved site level configurations during audits or inspections, as required to support audit and inspection activities.
- Ensures inspection outputs are accurate, traceable, and aligned with approved system configurations.
Governance & Continuous Improvement
- Participates in LMS governance forums led by the Global LMS System Owner, providing site level operational input and feedback.
- Supports continuous improvement of LMS processes, reporting on user experience within approved governance frameworks.
- Escalates system risks, recurring issues, or potential compliance concerns through defined training compliance and Quality channels.
The requirements:
- Bachelor’s degree in information systems, Life Sciences, Quality, Business, or a related discipline preferred, or equivalent.
- 3–5 years of experience administering an LMS or similar regulated enterprise system in a GxP regulated environment.
- Strong understanding of LMS configuration, training assignment requirements, and data integrity principles (e.g., ALCOA+) within a GxP regulated environment.
- Experience ensuring training records are audit-ready and supporting regulatory inspections or audits from a system perspective.
- Ability to interpret SOPs, training requirements, and regulatory expectations and translate them into system configurations and training assignment’s structure.
- Strong attention to detail, and accountability for maintaining accurate, complete, and compliant training records.
- Effective communication skills and ability to collaborate with Quality, training, IT, and site stakeholders.
Preferred Qualifications
- Experience supporting multiple enterprise learning platforms across regulated and non-regulated learning environments. Familiarity with computer system validation (CSV) concepts and system governance in regulated environments.
- Experience supporting global or multi-site LMS implementations.
- Formal training or certification in Quality systems, data integrity, or regulated systems administration.
- Experience participating in system governance forums or change management processes.
In return, you’ll be eligible for[1]:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit Union
[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
