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Senior Quality Assurance Specialist

2 months ago

Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
Job Title: Senior Quality Assurance Specialist

ADMA Biologics is seeking a highly skilled Senior Quality Assurance Specialist to join our team in Boca Raton, FL. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our products.

Key Responsibilities:
  • Perform quality assurance activities to ensure compliance with regulatory requirements
  • Conduct Change Review Board (CRB) to ensure changes are initiated, evaluated, and implemented in accordance with regulatory and corporate requirements
  • Coordinate and perform additional activities or projects, including the development of new procedures as assigned by QA management
  • Perform QA review and approval of equipment, process, automation, PD, IT, QC, AD, cleaning, and stability validation protocols and reports
  • Resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality-related issues, as needed
  • Utilize Quality Risk Management to identify, assess, control, and review any potential impact to process, product, or equipment
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 of experience in FDA/CBER regulated industry
What We Offer:
  • Competitive compensation package
  • Comprehensive benefits package, including 401K plan, medical, vision, life, and dental insurance, pet insurance, company-paid STD and LTD, company-paid holidays, three weeks of paid time off, tuition assistance, and easily accessible transportation options

ADMA Biologics is an Equal Opportunity Employer and uses E-Verify to confirm the employment eligibility of all newly hired employees.