Quality Control Inspector II

The Quality Control Inspector ll will report directly to the QC Inspector Lead, Quality Manager, or Director. This position is responsible for actively participating in Repligen’s ISO-9001 Quality Management System. The role involves inspecting, auditing, and reporting on incoming materials and processes using various visual inspection techniques and measuring equipment to ensure compliance with both organizational and customer quality standards.

“This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.”

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.

• Aware of continuous improvement and operational excellence

• 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.

• 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).

• 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

• Bachelor’s degree in science related discipline, or relevant industry experience, is preferred

• High School diploma or two-year technical degree or equivalent from an accredited technical institution is required. 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 2-5 years’ experience in Quality Assurance in an ISO-13485/9001 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.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate/salary range for this role, based in the United States of America is $33.00-$40.00. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.