Specialist I, Raw Materials

BioSpace; Boca Raton (FL); In loco; USD 55.000 - 75.000; Tempo pieno

Vantaggi offerti da questo lavoro

401K plan with employer match andimmed

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to the Boca Tri-Rail

Descrizione del lavoro

ADMA Biologics in Boca Raton, FL is seeking a Specialist I, Raw Materials who will perform quality control raw material processing and testing, following SOPs and cGMP guidelines.

Responsibilities include data entry, documentation, instrument calibration, and supporting method validations. Qualifications include a B.S./A.S. in a science and 0–3 years in pharma. We offer a comprehensive benefits package and opportunities for growth.

Competenze

• Bachelor's degree in a science discipline or equivalent experience in a regulated environment.
• 0–3 years of experience in a pharmaceutical company.
• Familiarity with FDA regulations and cGMP practices.

Mansioni

• Perform QC raw material processing, sampling and testing per SOPs.
• Complete testing documentation and data entry for procedures performed.
• Follow cGMP guidelines and SOPs in all work.
• Conduct instrument calibration or qualification as required.
• Support method validations and special projects as needed.
• Assist management on additional tasks and ensure compliant operations.

Formazione

B.S. or A.S. in Chemistry / Biochemistry / Biology or related science

Descrizione del lavoro

Job Description

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 Specialist I, Raw Materials in Boca Raton, Florida!

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 Specialist I, Raw Materials in Boca Raton, Florida!

Job Title: Specialist I, Raw Materials

Position Summary

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.

Essential Functions (ES) And 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, following general instructions on routine work and detailed instructions on new assignments.
• 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.

Experience Requirements

Job Responsibilities or Job Requirements

• Education 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).
• Experience Requirements: This position requires 0-3 years of experience in a pharmaceutical company.

Preferred Education And Experience:

• Preferred Education: B.S. or associate degree in Chemistry, Biochemistry, Biology or related science discipline, or equivalent working experience in a regulated environment (e.g., FDA).
• Preferred Experience: Work in a regulated environment (FDA, EPA, etc.) is preferred, but not required.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

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
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics 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.