Stability Associate

Location
Boca Raton, FL
Posted
Apr 23, 2021
Ref
26064
Required Education
Bachelors Degree
Position Type
Full time

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!

 

The Stability Associate will Perform and manage QC Laboratory Support initiatives related to Stability. Main Areas of focus:

  • Writes Interim and Final Stability data reports. Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
  • Manages stability inventories and performs stability pulls.
  • Writes and revises technical documentation. 
  • Assists QC in the design, implementation and maintenance of analytical assay trending reports.
Qualifications

Responsibilities:

  • Performs, manages and has expertise in QC stability and data analysis, such as:
  • Manages stability inventories and performs stability pulls.
  • Writes Interim and Final Stability data reports. Able to clearly present results of work, interpret data using standard statistical software and draw conclusions.
  • Writes and revises technical documentation for department areas of responsibility such as SOP’s, Stability Protocols, Specifications, etc.
  • Writes thorough change controls and investigations for quality systems.
  • Trains to become a Qualified Appearance Inspector and performs Appearance inspections.
  • Assists QC in the design, implementation and maintenance of analytical assay trending reports.
  • 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 record keeping is current, proper maintenance occurs and new requirements are identified as they arise.
  • Interacts with others, both within and outside the department, to provide customer support on issues and inquiries related to assigned areas of responsibility.
  • Performs, reviews and trains on processes performed within the department.
  • Assists in other functions, as assigned by the Manager. This may include Department areas of responsibility, such as Certificate of Analysis review, monitoring temperature controlled chambers, customer supports functions for QC Laboratory, etc.
  • 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 3-5 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

         Must have working knowledge of trending and/or stability analysis 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
  • 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.