Biopharmaceutical Compliance Professional

3 days ago


Boca Raton, Florida, United States ADMA BIOMANUFACTURING LLC Full time
The ideal candidate for this Senior Quality Assurance Specialist role will have a strong background in quality assurance and a deep understanding of FDA/CBER regulated industry. They will be responsible for ensuring compliance with regulatory requirements, primarily focusing on the efficacy and compliance of the change control management system, validation and qualification systems, Corrective Action and Preventive Action (CAPA) reports, and risk management policies and procedures.

Key Skills and Qualifications:
  • Proven experience in quality assurance, with a focus on FDA/CBER regulated industry.
  • Excellent communication and problem-solving skills.
  • Able to work effectively in a fast-paced environment and prioritize tasks accordingly.
  • Strong attention to detail and ability to maintain accurate records.
  • Knowledge of cGMP and regulatory compliance, including 21 CFR Parts 11, 210, 211, and 600.

Compensation and Benefits:

The estimated salary for this position is $90,000 - $110,000 per year, depending on experience. We also offer a comprehensive benefits package, including medical, vision, life, and dental insurance, 401K plan with employer match and immediate vesting, 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, and more.

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