QC Technician I at Repligen in Hopkinton, MA

Overview

The QC Technician I will report directly to the Director, QA/QC or Quality Manager.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role

is responsible for inspecting, auditing and reporting on in-procss and final inspection of Fluid Management Product at the Repligen Hopkinton, MA facility to ensure conformance to the organization and customer quality standards.

Responsibilities

The QC Technician I will be responsible for:

Conduct in-process and final inspection of Fluid Management single use assemblies and materials as part of manufacturing operations at the Hopkinton, MA facility.
Verify and apply finished goods part number label(s) to approved assembly and intermediate bag chamber materials according to the finished good part labeling specification.
Requires demonstrated use of inspection tools and ability read production blueprints
Working Knowledge of sampling plan(s).
Requires verbal or written communication to department management and production site lead of any noted Non-Conforming Material.
Reject any non-conforming material and support Root Cause Investigations.
Good organization skills and Microsoft Office software to accurately document and maintain associated paperwork and inspection results in a consistent and timely fashion.
Identify and communicate continuous improvement opportunities for the quality program for customers internal and external.
Maintain clean and orderly work area/ station.
Comply with safety regulations and personnel policy.
Other duties as assigned.

Qualifications

High School diploma or Two-year technical degree or equivalent from an accredited technical institution is preferred.
Familiar with medical devices, bioprocessing equipment, military or aerospace industry inspection practices and standards.
Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel, Word)
Minimum 0-2 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
Ability to communicate with multiple departments and associates.
Shares timely information with peers on daily progress.
Ability to contribute to project teams.
Focus and attention to detail is critical.
Understanding of Good Documentation Practices preferred.
Regularly required to bend, reach, stand and walk daily.

What Repligen Offers

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.