QA Specialist II, Supplier Quality

Location
Boca Raton, FL
Posted
Jun 08, 2021
Ref
26755
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 QA Specialist II, Supplier Quality in Boca Raton, FL!

 

This position will support Supplier Quality processes to ensure compliance with related regulatory requirements. 

 

ESSENTIALS OF THE JOB

  • Solid understanding of cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}), and other relevant quality compliance requirements of major regulatory agencies, and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
  • Ensures cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies, standards and procedures.
  • Perform internal audits to ensure adherence to ADMA policies and procedures and FDA regulations
  • Monitor and execute supplier quality agreements to ensure compliance with ADMA procedures
  • Perform product complaint investigations
  • Maintain the Approved Supplier List (ASL) to ensure that Suppliers are appropriately qualified, classified and maintained for the products and services provided.
  • Maintains the Supplier Complaint Process (SCARs) and work with suppliers to resolve materials discrepancies. Support in an evaluation of supplier corrective action plans to resolve quality related issues timely. 
  • Supports Supply Chain and QA Compliance needs and ensures compliance with regulatory requirements related to Suppliers.
  • Manage the performance review of suppliers, to enable full transparency of suppliers' performance across the stakeholders to ensure supplier improvement where necessary.
  • Prepares and assists with communicating applicable vendor notifications and applicable external audit metrics (i.e. audit & report completion, schedule adherence, audit CAPA pla(s), etc.).
  • Coordinates and performs any additional activities or projects assigned by QA Management
  • Escalate issues to quality management in timely manner and work with management to address and remediate issues.

 

Qualifications

Education Requirements:                  

Bachelors Degree preferred.

 

Experience Requirements:              

3-5 years of experience in pharmaceutical or biotechnology industry or other related industry. Experience in Supplier Quality.

 

Other Essential Knowledge:              

Detail oriented, and has knowledge of scientific, medical and regulatory terms.  Ability to use personal computer and software including word processing, spreadsheet and database.  Demonstrated organizational and coordination skills, with close attention to detail and accuracy.  Good inter-personal and oral communication skills to effectively train personnel.  Demonstrated good problem solving skills with minimal supervision.  Mathematical skills including the use of calculations involving fractions, decimals and percentages.

 

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
  • Company paid shuttle to the Boca Tri-Rail station

 

 

ADMA Biologics, Inc. 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