Quality Assurance Inspector

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.

Minimum Education Requirement:

• High School / GED

Required Experience (3+ years):

• Relevant experience

Preferred Experience:

• 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).

How you will thrive and create an impact:

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.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions):

Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures. Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on routine basis. Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and ski