Specialist I, Raw Materials

About the role

ADMA Biologics is a biopharmaceutical company dedicated to creating superior products for immunodeficient patients at risk for infection. The Specialist I, Raw Materials performs quality control raw material processing and testing, following general instructions on routine work and detailed instructions on new assignments.

Responsibilities

• Perform quality control raw material processing, sampling, and testing independently according to approved Standard Operating Procedures.
• Complete testing documentation and data entry as required for procedures and tests performed in-house and at contract labs.
• Utilize cGMP practices in documentation and execution of job functions.
• Perform testing as needed to generate data for method validations and other special projects.
• Fulfill requests from management for assistance in other matters as needed.
• Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
• Perform instrument calibration or qualification according to written procedures.

Requirements

• B.S. or associate degree in Chemistry, Biochemistry, Biology, or related science discipline, or equivalent working experience in a regulated environment (e.g., FDA).
• 0-3 years of experience in a pharmaceutical company.
• Strict adherence to FDA regulations and company policies governing activities, including completion of required compliance training, accurate documentation, and adherence to data privacy regulations.
• Proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education on relevant FDA regulations.

Preferred: Work experience in a regulated environment (FDA, EPA, etc.).

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life, and Dental Insurance
• Pet Insurance
• Company-paid Short-Term Disability (STD) and Long-Term Disability (LTD)
• Company-paid holidays
• 3 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