Specialist I, Raw Materials

Key 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.
• Strict adherence to FDA regulations and company policies.
• Completion of required compliance training.
• Accurate documentation of interactions.
• Adherence to data privacy regulations.
• Proactive participation in compliance reviews.
• Prompt reporting of any potential issues.
• Ongoing education to stay updated on relevant FDA regulations.

Requirements & Tech Stack

• 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.
• Work in a regulated environment (FDA, EPA, etc.) is preferred, but not required.