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.
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.
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 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.
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 for this role, based in the United States of America is $24/Hr -$30/Hr.
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.
