Overview
The QC Technician I will report directly to the Director, QA/QC or Quality Manager.
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-procss and final inspection of Fluid Management Product at the Repligen Hopkinton, MA facility to ensure conformance to the organization and customer quality standards.
Responsibilities
The QC Technician I will be responsible for:
- Conduct in-process and final inspection of Fluid Management single use assemblies and materials as part of manufacturing operations at the Hopkinton, MA facility.
- Verify and apply finished goods part number label(s) to approved assembly and intermediate bag chamber materials according to the finished good part labeling specification.
- Requires demonstrated use of inspection tools and ability read production blueprints
- Working Knowledge of sampling plan(s).
- Requires verbal or written communication to department management and production site lead of any noted 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
- High School diploma or Two-year technical degree or equivalent from an accredited technical institution is preferred.
- 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.
- Regularly required to bend, reach, stand and walk daily.
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.