Sr. Quality Data Analyst (Stability/Biological Statistics)

Location
Boca Raton, FL
Posted
Aug 25, 2020
Ref
22570
Discipline
Quality, Quality Control
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 Senior Quality Data Analyst!

Sr Quality Data Analyst focuses on statistical analysis of biological products for

STABILITY program & LABORATORY trending:
  • Stability Programming including managing, analysis, and reporting for product stability studies and laboratory trending reports. Leads the designs, conduct and implementation of Stability and Trending programs.
  • Prepares/revises documentation such as SOPs, Stability Protocols, and Quality Systems reports, etc.

Designs, conducts and implements training.

Qualifications

Responsibilities:
  • Performs, manages and has expertise in assigned areas of responsibility, which primarily includes providing QC functions, such as:
  • 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.
  • Designs, implements and maintains 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 QC department functions.
  • 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, customer supports functions for QC Laboratory, monitoring temperature-controlled chambers, 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 guidelines. Working knowledge of trending and/or stability analysis in a regulated environment a plus.

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 and Personal Days
  • 3 Weeks' Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Company paid 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.