ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Technician I, GxP Software Support in Boca Raton, FL!
Position Summary:
The Technician I, GxP Software Support will support the end users of various GMP systems by maintaining master data, providing training, supporting end users, and end users accounts, while ensuring compliance. This position is to be a technical liaison between the business needs of GMP software system users and the Data Integrity department. This position requires functional knowledge of a QC Laboratory, regulations including GAMP and cGMP, and interacts with multiple technical and non-technical personnel.
This is an onsite position in our Boca Raton, FL site.
Essential Functions and Responsibilities:
- Supports and maintains software for the Laboratory IT Systems including, but not limited to, LabVantage LIMS, Empower 3, SoftExpert, MES, Kneat, and LabX.
- Supports end users in the QC/AD/PD Laboratory and manufacturing areas by responding to tier 1 help desk tickets for all cGMP applications, including onsite troubleshooting of issues encountered within software.
- Provide end user support and training for various IT systems.
- Manage user accounts and security roles for IT systems.
- Provide data for analysis utilizing available data and reporting tools.
- Responds and resolves system user inquiries.
- Responds to both help desk tickets and direct communication with end users to resolve issues with cGMP applications within the BioCenter and Manufacturing user base.
- Develops and maintains Software Standard Operating Procedures.
- Partner with quality control, quality assurance, analytical and process development, IT, facilities and plant operations staff on a regular basis to understand software related requirements and business processes. Analyze and identify enhancements to the current system functionality to improve practices and achieve efficiency.
Experience Requirements:
- Education Requirements: Bachelor’s degree in computer sciences, biological sciences, or related discipline preferred or equivalent experience.
- Experience Requirements: One to three years’ experience in information systems and/or a laboratory/facilities setting related to information systems. Basic system administration of cGMP applications. Knowledge of industry regulations (such as GAMP, cGMP, cGLP, GDP, etc.) is required. Direct experience working in a laboratory a plus.
Compliance Requirements:
The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.
In addition to competitive compensation, we offer a comprehensive benefits package including:
- 401K plan with employer match and immediate vesting
- Medical, Vision, Life and Dental Insurance
- Pet Insurance
- Company paid STD and LTD
- Company Paid Holidays
- 3 Weeks’ Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Free shuttle to the Boca Tri-Rail station
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.