Overview

The QC Inspector will report directly to the QC Inspector Lead, QC Manager or Director.

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 incoming materials and processes using various visual techniques and measuring equipment to ensure conformance to the organization and customer quality standards.  

Responsibilities

• Conduct inspection of materials, from suppliers, and approves or rejects according to documented processes.
• Verify and apply part number label(s) to approved materials according to the inventory part labeling specification.
• Requires demonstrated use of inspection tools (i.e.: Calipers, Micro-hite, Comparator etc.)

• Able to assess and interpret engineering drawings, specifications, purchase orders, statement of work and standards to determine quality status.
• Knowledge of performing on machined parts based on drawing requirements using precision measuring tools.
• Aware and follow SDS (Safety Data Sheets) related to chemical handling of materials.
• Working knowledge of Geometric Dimensioning and Tolerancing GD&T.
• Working knowledge of sampling plan(s).
• Requires verbal or written communication to management of all Non-Conforming Material.
• Lead any non-conforming material and support Root Cause Investigations to closure.
• 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.
• Supporting First Article Inspection (FAI).
• Support Internal, Supplier and Customer Audits.
• Supporting Corrective Action, Deviations and Complaints.
• 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.
• Machine shop experience in the quality discipline or a related field will be considered.
• 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 1-3 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.