QA Engineer I

Description

The role sits in the quality assurance team at a company that develops and produces affinity resins, used by customers in cGMP manufacturing. The site is in Naarden, and the work runs Monday to Friday, on site.

The team makes sure quality standards and regulatory compliance are applied consistently, and works with other functions on product quality and continuous improvement across the site's products and customer projects.

Responsibilities

• Keep the Quality Management System up to date and keep improving it.
• Check batch records, issue Certificates of Analysis and release products to the market.
• Log and review root cause investigations into deviations and complaints in TrackWise.
• Weigh customer needs when solving problems, aiming for better efficiency and customer satisfaction.
• Answer customer questions about the company's products.

Requirements

• A HBO degree in chemistry, biology, biotechnology, engineering or a related scientific or technical field.
• More than 3 years of quality assurance experience, or a Master of Science, or equivalent relevant experience in quality assurance.
• Experience with Quality Management Systems in an ISO9001 or GMP environment.
• Experience with a document management system.
• Experience using quality management software such as TrackWise.
• Verbal and written English at HBO or scientific level.
• Sound knowledge of quality standards such as cGLP, GMP or ISO9001, and the ability to apply them in daily work.
• Good social and communication skills.
• Good planning and organisational skills.
• Ability to work independently and collaborate with cross-functional teams.
• Willingness to question current compliance practices to find better ways of working.
• Strong judgement and creative problem-solving skills.

Conditions

Standard Monday to Friday schedule.

Primarily on-site in an office setting; working from home is possible by agreement with the QA supervisor.

You plan, monitor, carry out and report your QA activities with limited supervisor support.

You work closely with all functions involved in developing and manufacturing products, across a wide range of QA activities.

Applicants are considered without regard to background, in line with equal opportunity rules.

Benefits

• A welcoming, open and safe workplace that encourages collaboration and personal growth.
• Training and career development, with room to move sideways and upward in the organisation.
• Competitive benefits and flexible working hours.