Quality Control Inspector I
Repligen
Summary
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.
Job description
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.
Requirements
- 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
Benefits
- Paid time off
- Health insurance
- Dental insurance
- Vision insurance
- Retirement benefits
- Flexible spending accounts
- Variable cash programs
- Equity
Company overview
Repligen Corporation is a global life sciences company headquartered in Waltham, Massachusetts, specializing in the development and commercialization of innovative bioprocessing technologies and systems. Founded in 1981 and publicly traded on NASDAQ under the symbol RGEN, the company focuses on providing advanced tools and solutions that enable efficiencies in the manufacturing of biological drugs. Repligen's product portfolio spans four main categories: filtration and fluid management (representing 58% of revenue), chromatography systems, proteins, and process analytics. The company serves a diverse customer base including biopharmaceutical companies, contract development and manufacturing organizations (CDMOs), and other life science entities worldwide. With over 1,800 employees globally and operations across North America, Europe, and Asia-Pacific, Repligen has established itself as a trusted partner in bioprocessing, supporting the production of monoclonal antibodies, recombinant proteins, vaccines, cell and gene therapies, and other advanced biologics. The company's mission is to inspire advances in bioprocessing through technological innovation and strategic partnerships.