Stability Associate

Job DetailsJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category ManufacturingDescription

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 Stability Associate!

Responsible for executing stability studies of plasma-derived biopharmaceutical products in a cGMP environment.  Areas of focus are planning and executing studies, managing study inventory, and scheduling and performing stability pulls.  Additional stability related support activities include writing protocols, monitoring and trending data, and writing stability reports.

 

Qualifications

• Responsible for all day-to-day activities of the Quality Control Stability program:
• Plans and executes stability studies.
• Manages stability inventories.
• Schedules and performs stability pulls.
• Monitors the completion of test data.
• Supports the management of temperature-controlled chambers.
• Supports and assists in all other aspects of the Quality Control Stability program, as needed:
• Preparation and revision of technical documentation for department areas of responsibility such as Procedures, Stability Protocols, Specifications, etc.
• Perform and interpret statistical analysis of trends by linear regression, ANCOVA, and control charting using appropriate data analysis software.
• Preparation and revision of stability data reports with adherence to regulatory and company guidelines
• Preparation of thorough change controls and investigations for quality systems.
• Is technically proficient in Microsoft and JMP software. 
• Has expertise and guides others in cGMP and cGDP practices in documentation and execution of job functions.
• Ensures compliance with all regulatory requirements by verifying procedures are being followed, all recordkeeping is current, proper maintenance occurs and new requirements are identified as they arise.
• Effectively communicates critical stability and quality related information to appropriate teams. 
• Is a subject matter expert for areas of responsibility for internal and external customers and participates in internal and external audits.
• Identify opportunities for and participate in continuous improvements to increase efficiency and compliance
• Performs, reviews and trains on processes performed within the QC Laboratory Support department.
• Assists in other QC, regulatory support, and data analysis functions, as assigned by the Manager.

Education Requirements:

Requires a Bachelor’s or Masters’ degree in Biology, Chemistry, Mathematics or related scientific field.  Must include statistics.

Experience Requirements:     

 Requires at least 1-3 years of experience in a regulated laboratory setting, and previous work experience in a regulated environment (FDA, EPA, etc.) is required.  Must be familiar with GLP and GMP guidelines.   Must have working knowledge of stability program requirements in a regulated environment.       

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Dental Insurance, Life and Disability
• 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.