Quality Assurance Inspector

Avantor•Fountain, OH

1d•Onsite

About The Position

The Opportunity: Avantor , a Global Fortune 500 company, is looking for a dedicated Quality Inspector to optimize our VWR Chemical organization. This Solon, OH role is full-time, working on-site Monday through Friday 2- 10:30 PM. Avantor® sets science in motion by enabling innovation across the life sciences and technology industries. The Solon location specializes in quality chemical down packing of dry chemicals and liquid solutions; finished packaging; in- house testing as well as contract medical device manufacturing. The site supports sustainability and meets environmental goals. In 2024, Avantor/ Solon launched a new recycling and reuse process supported by the Material Review Board and EHS team. Utilizing business level communication skills, the second shift Quality Assurance Inspector will: Comply with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality. While keeping customer interests and regulatory requirements in mind, ensuring customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements Ensuring technicians understand and follow documented Avantor/ VWR procedures and GMP / GDocP requirements. Ensure customer requirements are met. Verify adherence to policies, procedures, and work instructions. Ensure documentation and physical product segregation and containment of non-conforming material identified during the production process. Review production documentation for accuracy, completeness, and GDocP compliance. Assist in correcting order issues and ensure actions are appropriate. Communicate issues / concerns to area owner and direct manager. Ensure that the work area is in a state of “audit readiness”. Perform inspection tasks by following established work instructions and procedures, by using required tools, methods and equipment, to determine acceptability of product, components, and documentation. Perform pre-fill, in-process, and final inspections with the aid of documented work instructions. Provides first response in QA oversite to production activities. When issues occur, stabilize the situation and escalate as needed. Give immediate go/no-go decisions for issues on the production floor, especially related to time-restricted product. Stop production when a critical non-conformance (NCM) is observed and follow appropriate NCM procedures. Document non-conformances following applicable Avantor/VWR procedures and work instructions. Documenting quality production issues discovered during inspection. Utilize problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues. Adheres to Avantor/ VWR QMS policies. Walk the floor to observe, train, and facilitate / support change. Performing other duties as assigned.

Requirements

High School / GED
Relevant experience (3+ years)

Nice To Haves

In a Quality Assurance role within the medical device, biotech, food, or pharmaceutical industry.
With current Good Manufacturing and Documentation practices (cGMP, cGDocP).
Multi- tasking and prioritizing efficiently.
Knowledge of ISO 9001, ISO 13485, 21 CFR 820 and 21 CFR 11 standards.
Conducting root cause analysis as it relates to non‑conforming material investigations.
Collaboration skills (IE: Microsoft Outlook).

Responsibilities

Comply with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
While keeping customer interests and regulatory requirements in mind, ensuring customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements
Ensuring technicians understand and follow documented Avantor/ VWR procedures and GMP / GDocP requirements.
Ensure customer requirements are met.
Verify adherence to policies, procedures, and work instructions.
Ensure documentation and physical product segregation and containment of non-conforming material identified during the production process.
Review production documentation for accuracy, completeness, and GDocP compliance.
Assist in correcting order issues and ensure actions are appropriate.
Communicate issues / concerns to area owner and direct manager.
Ensure that the work area is in a state of “audit readiness”.
Perform inspection tasks by following established work instructions and procedures, by using required tools, methods and equipment, to determine acceptability of product, components, and documentation.
Perform pre-fill, in-process, and final inspections with the aid of documented work instructions.
Provides first response in QA oversite to production activities.
When issues occur, stabilize the situation and escalate as needed.
Give immediate go/no-go decisions for issues on the production floor, especially related to time-restricted product.
Stop production when a critical non-conformance (NCM) is observed and follow appropriate NCM procedures.
Document non-conformances following applicable Avantor/VWR procedures and work instructions.
Documenting quality production issues discovered during inspection.
Utilize problem solving tools such as 5M+E, 5 Why’s, or other root cause analysis tools / methods to identify and permanently resolve issues.
Adheres to Avantor/ VWR QMS policies.
Walk the floor to observe, train, and facilitate / support change.
Performing other duties as assigned.