Specialist I, Raw Materials

ADMA Biologics; Boca Raton (FL); Vor Ort; USD 45.000 - 65.000; Vollzeit

Benefits dieser Stelle

401K plan with employer match and vest

Medical, Vision, Life and Dental

Pet Insurance

STD and LTD

Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Tri-Rail accessibility

Free shuttle to Boca Tri-Rail

Zusammenfassung

ADMA Biologics, a biopharmaceutical company focused on immunodeficient patients, seeks a Specialist I, Raw Materials in Boca Raton, FL. The role performs quality control processing and testing of raw materials under cGMP, following SOPs, with data entry and documentation responsibilities.

Education includes a science degree or equivalent regulated-environment experience; 0–3 years in pharma is acceptable. Strong adherence to FDA requirements is essential, along with calibration and testing

Qualifikationen

• 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.
• Experience in a regulated environment (FDA, EPA) is preferred but not required.
• Ability to follow SOPs and adhere to cGMP guidelines.

Aufgaben

• Perform quality control raw material processing, sampling, and testing independently according to SOPs.
• Complete testing documentation and data entry for procedures and tests performed in-house and at contract labs.
• Utilize cGMP practices in documentation and execution of job functions.
• Perform testing to generate data for method validations and other projects.
• Fulfill management requests and act on compliance requirements as needed.
• Accountability for SOPs and cGMP adherence.
• Perform instrument calibration or qualification per procedures.

Kenntnisse

Quality control

Documentation

cGMP compliance

Data entry

Laboratory testing

Ausbildung

Bachelor's degree in Chemistry/Biochemistry/Biology or related science

Associate degree in Chemistry/Biochemistry/Biology or related science

Tools

Laboratory instruments

Calibration equipment

Jobbeschreibung

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

Job Description

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.

Job Responsibilities or Job Requirements

Experience 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 comprehensivebenefits 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 Biologicsis an Equal Opportunity Employer.