Quality Inspector

Avantor•Devens, MA

3d•$45,500 - $79,500•Onsite

About The Position

The Opportunity: Avantor is looking for a Quality Inspector to ensure quality standards are met in a biopharma production environment. This role will be a full-time position based out of our Devens, MA office. How you will thrive and create an impact: Perform Quality Inspection on incoming raw material components from suppliers. Evaluate all incoming documentation (packing list, Certificates of Conformance, Calibration Certificates, etc.) for compliance. Perform inspection disposition into ERP system. Follow AQL sampling plan. Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality. Ensures documentation and physical product segregation and containment of non-conforming material. Reviews production documentation for accuracy, completeness, and GDP compliance. Communicates issues / concerns to area owner and direct manager. Ensures that the area is in a state of “audit readiness” at all times. Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components and required documentation. Perform thorough inspections of raw materials, in-process samples, intermediate products, and final biopharmaceutical products to verify compliance with specifications and quality standards. This may involve visual inspection, dimensional measurement, and testing using various analytical equipment. Alerts management when a non-conformance (NCM) is observed and follows appropriate NCM procedures. Document any deviations or non-conformances, following Avantor procedures and WI, encountered during inspections or routine activities. Ensures cleanliness of work areas. Performs other duties as assigned by Manager. Follows applicable safety procedures.

Requirements

Education: High School completion or equivalent (GED) required.
Experience: Minimum of 1 year related experience and/or training in a regulated industry is required.
Good communication and interpersonal skills.
Good attention to detail.
Ability to read, understand, and follow procedures.
Ability to escalate non-conforming material issues according to established procedures.
Familiarity with QMS.
Self-motivated and ability to work independently and with a team.
Good mathematics skills.
Knowledge of inspection tools and techniques.

Nice To Haves

Experience in a Quality role within the medical device, biotech, or pharmaceutical industry is preferred.
GMP knowledge is preferred.

Responsibilities

Perform Quality Inspection on incoming raw material components from suppliers.
Evaluate all incoming documentation (packing list, Certificates of Conformance, Calibration Certificates, etc.) for compliance.
Perform inspection disposition into ERP system.
Follow AQL sampling plan.
Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
Ensures documentation and physical product segregation and containment of non-conforming material.
Reviews production documentation for accuracy, completeness, and GDP compliance.
Communicates issues / concerns to area owner and direct manager.
Ensures that the area is in a state of “audit readiness” at all times.
Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components and required documentation.
Perform thorough inspections of raw materials, in-process samples, intermediate products, and final biopharmaceutical products to verify compliance with specifications and quality standards. This may involve visual inspection, dimensional measurement, and testing using various analytical equipment.
Alerts management when a non-conformance (NCM) is observed and follows appropriate NCM procedures.
Document any deviations or non-conformances, following Avantor procedures and WI, encountered during inspections or routine activities.
Ensures cleanliness of work areas.
Performs other duties as assigned by Manager.
Follows applicable safety procedures.