What are the responsibilities and job description for the ARx Technical Operator- 2nd shift position at ARx, LLC?
Job Description
Job Description
Must be able to work 2nd shift hours. The training is provided on 1st shift
Job Summary :
Responsible for assisting in developing, scaling up and validating processes used for producing specialty drug delivery products in a manner compliant with 21CFR211 and all other relevant regulatory requirements on the ARx packaging lines.
Essential Functions :
- Work with the manufacturing and process engineers to develop modified and new processes for producing specialized drug delivery therapeutic products. Works in close collaboration on cross-functional teams with Engineering, Operations, and Quality to accomplish successful outcomes. Will work on the packaging line as needed.
- Provides oversight to packaging process, including spending significant time on the line and monitoring the process.
- Performs a variety of technical line tasks with Engineering and Operations guidance, which include but are not limited to the execution of experimental and validation protocols for packaging in compliance with 21CFR211 Regulatory standards.
- Contributes to designing experiments, conducts experiments, collects data and performs data analysis and interpretation. Generates reports and makes recommendations based on sound data interpretation.
- Contributes to generating cleaning processes and change over requirements.
- Contributes to design records required to support product development and commercial production.
- Accurately performs work assignments and collects information for computer data analysis.
- Effectively communicates and interacts with other associates and customers.
- Participates in problem-solving efforts.
- Proactively works to develop foundational knowledge base on relevant process technologies.
- Develops and maintains awareness of business strategies and plans.
- Conducts all work activities in a safe, responsible and professional manner consistent with all Company Policies, Quality Systems Requirements and Relevant Regulatory Standards (e.g. 21CFR211).
Additional Responsibilities :
Job Specifications :
