QA specialist

Avantor Sciences; Hillegom; On-site; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Bonus

Job summary

Avantor's Hillegom site is seeking a dedicated Quality Inspector to ensure customer and regulatory requirements are met across manufacturing, filling, labeling, and documentation.

You will perform in-process and final inspections, review production documentation for GDP compliance, and support root-cause analysis and corrective actions while upholding GMP and GDP standards in a regulated biopharma environment.

Qualifications

• Must be able to balance multiple tasks and priorities efficiently.
• Knowledge of ISO 9001, ISO CFR 820, 21 CFR 11, EXCiPACT is preferred.
• Experience in root cause analysis related to non-conforming material investigations is desirable.

Responsibilities

• Inspect product and review documentation throughout manufacturing, filling, labeling, and assembly to ensure compliance.
• Perform pre-fill, in-process, and final inspections using established work instructions.
• Stop production when a non-conformance is observed and follow NCM procedures.
• Document non-conformances and trends; support investigation and corrective actions.
• Ensure audit readiness and maintain GDP and GMP compliance.

Skills

Multitasking

Root cause analysis

Communication skills

Education

High School diploma or GED

Bachelor's degree

Tools

Outlook

Word

Excel

Access

Job description

If you are ready to discover your greatest potential and lift your career to the next level, Avantor's brand new site in Hillegom offers challenging opportunities in a biopharma environment!

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers.

At Avantor, we set science in motion to create a better world. To achieve this mission, we are currently looking for a one-of-a-kind Quality Inspector.

In this role, you will ensure customer and regulatory requirements have been met by inspecting product and review of documentation throughout all aspects of the production process (e.g., manufacturing, filling, and labeling / assembly, etc.). You will also ensure compliance with all applicable standards and regulations (e.g., ISO 9001, ISO CFR 820, 21 CFR 11, ISO , and EXCiPACT), Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs). You will be responsible for providing Event and Complaint investigation support to other team members.

• Comply with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
• Keep customer interests and regulatory requirements in mind, ensure customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensure other technicians understand and follow documented VWR Solon procedures and GMP 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 GDP compliance.
  • Assist in correcting order issues and ensure actions that are taken are appropriate.
  • Communicate issues / concerns to area owner and direct manager.
  • Ensure that the area is in a state of “audit readiness” at all times.
• Perform 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 documentation.
• Perform pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required.
• Stop production when a non-conformance (NCM) is observed and follow appropriate NCM procedures.
• Document non-conformances following applicable VWR Solon procedures and work instructions.
• Document and trend any quality production issues discovered during the course of inspection duties.
• Ensure cleanliness of work areas during the inspection processes.
• Utilize problem solving tools such as 5M+E, 5 Why's, or other root cause analysis tools / methods to identify and permanently resolve issues.
• Adhere to VWR Solon's QMS and VWR Policies, where applicable.
• Walk the floor to observe, train, and facilitate / support change.
• Perform other duties as assigned.

• High School completion or equivalent (GED) and a minimum of 3 years related experience and/or training in a regulated industry is required; OR
• Bachelor's degree is required
• Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry is preferred

YOUR KNOWLEDGE SKILLS AND ABILITIES

• Must be able to balance multiple tasks and prioritize efficiently
• Knowledge of ISO 9001, ISO CFR 820, 21 CFR 11, ISO , or EXCiPACT standard is preferred
• Demonstrated experience or knowledge in conducting root cause analysis as it relates to non‑conforming material investigations
• Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
• Good communication skills

• A challenging job in a service-minded company within an international working environment.
• You can count on an attractive salary package including a bonus and other extra-legal benefits.