Overview
Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing — and to help our customers make a difference in the world.
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.
- 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.
Qualifications
- High School diploma or 2-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.
- Minimum 2-5 years of experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
- 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 of experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
What Repligen Offers
Excellent Benefits!
- Health Insurance available on day one
- 4 Competitive Medical Plan Options
- Dental, Vision, Life and Disability Insurance Plans
- 401K
- Health Care Savings Account
- Well Being Programs
- 20 Days of PTO
- Tuition Reimbursement Program