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.
The QC/QA Inspector II will report directly to the Quality Lead, Quality Manager or Director.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System.
This role is supporting both QA and QC for the Incoming Inspection Global Release team in our Shrewsbury location.
Responsibilities Conduct inspection of incoming materials from suppliers and approve 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 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.
Supporting Corrective Action, Deviations and Complaints.
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.
Quality document updates including inspection plans, SOPs, creation, and review.
Supporting First Article Inspection (FAI).
Support Internal, Supplier and Customer Audits.
Support all aspects of non-conforming material reports including review, investigations, and approval.
Comply with safety regulations and personnel policy.
Qualifications Bachelors degree in science related discipline, or relevant industry experience.
Familiar with medical devices, bioprocessing equipment, military or aerospace industry inspection practices and standards.
Able to interpret engineering drawings, specifications, purchase orders, statement of work.
Requires demonstrated use of Microsoft Office tools (Outlook, Excel, Word) Minimum 2-5 years experience in QA in an ISO 9001 or ISO 13485 certified Quality Management System or equivalent.
Ability to communicate with multiple departments and associates.
Ability to contribute to project teams.
Focus and attention to detail is critical.
Understanding of Good Documentation Practices (GDP) PDN-9d236540-1d70-4452-8fe3-e3dc93b07ab7