QC Inspector I (Hopkinton, MA 2nd Shift Operations) at Repligen in Hopkinton, MA

Overview

We are seeking a QC Inspector I to join our growing Quality Department team in Hopkinton, MA for 2nd shift operations (M-F).

The QC Inspector I will report directly to the QA/QC 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 in-process and final inspection of single use assembly parts at the Hopkinton, MA production facility, using various visual techniques and measuring equipment to ensure conformance to the organization and customer quality standards.

Responsibilities

The QC Inspector I will be responsible for:

Conduct inspection of single use assembly designs of customers and approves or rejects according to documented processes.
Verify and apply part number label(s) to approved production materials according to the inventory part labeling specification.
Requires demonstrated use of inspection tools (i.e.: Calipers, Micro-hite, rulers etc.)
Working Knowledge of sampling plan(s).
Requires verbal or written communication to management of all 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

Qualifications for the QC Inspector I role include:

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 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.

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.