QA specialist

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!

Solliciteer na het lezen van de volgende vaardigheids- en kwalificatievereisten voor deze functie.

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 13485, 21 CFR 820, 21 CFR 11, ISO 17025, 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 13485, 21 CFR 820, 21 CFR 11, ISO 17025, 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.
• You will join a company that values its employees and helps them develop internally. xnkfpon
• You will be working in our new site in Hillegom, where you will have the opportunity to take initiatives and be part of a new journey towards Avantor's success.