Senior Quality Assurance Expert

6 days ago


Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
Role Overview

We are seeking a highly experienced Senior Quality Assurance Specialist to join our team at ADMA Biologics in Boca Raton, FL. This role will play a crucial part in ensuring the efficacy and compliance of our change control management system, validation and qualification systems, CAPA reports, and risk management policies.

Responsibilities
  • Conduct Change Review Board (CRB) meetings to ensure that changes are initiated, evaluated, properly classified, authorized, and implemented in accordance with regulatory and corporate requirements.
  • Coordinate and perform additional activities or projects as assigned by QA management, including developing new procedures.
  • Perform QA review and approval of equipment, process, automation, PD, IT, QC, AD, cleaning, and stability validation protocols and reports.
  • Maintain proficiency in cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as corporate policies and procedures.
  • Resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality-related issues.
  • Utilize Quality Risk Management to identify, assess, control, and review any potential impact on process, product, or equipment.
  • Work closely with the Validation team to ensure documentation is accurate and complete.
Requirements
  • Bachelor's Degree in a field related to the title of the position.
  • Five to eight years of experience in the pharmaceutical or biotechnology industry, with a minimum of four years in FDA/CBER-regulated industries.
Compensation and Benefits

We offer competitive compensation and a comprehensive benefits package, including:

  • 401(k) plan with employer match and immediate vesting.
  • Medical, Vision, Life, and Dental Insurance.
  • Pet Insurance.
  • Company-paid STD and LTD.
  • Company-paid Holidays.
  • Three 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.
Estimated Salary Range

The estimated salary range for this role is $80,000 - $120,000 per annum, depending on experience.



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