Manufacturing Associate I - 2nd Shift, ATF

Overview

Reporting to the Manufacturing Supervisor, the Manufacturing Associate will perform various activities in the production of alternating tangential flow single use devices. The ability to successfully cross-train into other areas / functions may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring that the department's production and quality goals are met. Applicants must have strong technical knowledge and problem solving skills. The candidate must be able to follow oral and written instructions accurately (English), learn complex tasks quickly, and complete tasks in a timely manner. Many functions require standing for long periods of time and some frequently lifting up to 50 lbs. The successful candidate will actively follow Repligen ISO 9001 Quality Management System in support of the manufacturing processes and final product testing. Experience working in a classified cleanroom, and knowledge of GMP / ISO / document controlled processes would be beneficial. Attention to detail and the ability to work both independently and in a team environment are essential. Most operations require good hand-eye coordination and manual dexterity. The candidate must be computer literate with some MS Office experience.

Responsibilities

Essential Duties :

• Assembly of single use ATF devices. Following SOPs and training, assembly of suATF devices ensuring quality and quantity are produced. This includes assembling components for suATF devices, reading and following drawings, maintaining lot traceability of components, using machine to conduct integrity testing, using tools during assembly (including hand tools, torque wrenches, tube cutters), visual inspection of components, and packaging devices. Ensure all process documentation is completed correctly and concisely in electronic batch records. Ensure tooling is clean, functional, and operational. May perform some data entry as required. Tasks include frequently lifting devices up to 50 lbs.

Additional Duties :

Other Functions :

Qualifications

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