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.
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 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