QA Specialist

QA Specialist – Magle Biopolymers

Experienced, Pragmatic and Quality Focused

About Magle Biopolymers

Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technology. We develop and manufacture advanced polymer-based materials used in medical products, contributing to improving patients’ lives.

As a CDMO entity within the group, Magle Biopolymers operates in a regulated environment with high quality requirements. Quality, accountability, and cross-functional collaboration are core elements of our daily work, and we continuously strive to improve our processes and solutions.

We are looking for an experienced QA Specialist with a solid background in GMP and or ISO 13485. You enjoy working close to production, supporting daily operations and ensuring that quality decisions are made efficiently and based on sound judgement. You have a pragmatic mindset and thrive in a hands on QA role where your work contributes directly to reliable and safe production.

About the Position

As QA Specialist, you will support the production and quality organisation with routine and operational QA responsibilities. You work independently with quality issues, manage documentation and ensure that processes and decisions follow established quality principles. Your work has a direct impact on product quality and delivery reliability.

As you will support our two sites, you will need to be present in both Køge and Hårlev.

Key Responsibilities

Support production with QA responsibilities

• Perform batch record review and support batch release activities in close collaboration with the QA team,

• Handle deviations, CAPA, change controls and other day to day quality issues,

• Participate in root cause investigations and help define effective corrective and preventive actions,

• Ensure that documentation is clear, correct and completed according to internal procedures.

Work with continuous improvements

• Identify opportunities to improve quality processes and routines within production,

• Contribute to LEAN initiatives and other improvement activities where relevant,

• Support implementation of revised procedures and new work practices.

Collaborate across functions

• Work together with production, QC, supply chain and other departments,

• Provide guidance on quality requirements and help colleagues apply risk based and pragmatic QA thinking,

• Support internal audits and follow up on audit actions where needed.
  

We Imagine That You

Are an experienced QA professional

• With 3+ years of QA experience from GMP or ISO 13485 environments,

• Comfortable working independently with operational quality tasks.

Pragmatic and efficient

• Able to identify what is critical and what is not,

• Structured, quick in prioritisation and solution oriented.

Quality minded and collaborative

• Skilled in communication and able to guide colleagues in quality matters,

• A team player who works well with production and other departments.

Qualifications

• Degree in Life Science, Engineering, Pharmacy or similar,

• Strong understanding of quality principles and documentation practices,

• Good command of Danish and English, spoken and written.

We offer

• A role close to production where you can make a direct impact

• A professional environment with committed colleagues

• Opportunities for development and increased responsibility over time

Culture and Values

At Magle Group, we work according to the IMPACT values:

Innovate – we continuously develop and improve

Motivate – we engage and support each other

Positive – we approach challenges constructively

Accountable – we take ownership of quality and results

Customer – we focus on customer and patient needs

Teamwork – we succeed through collaboration

Application

We invite candidates for interviews on an ongoing basis and encourage you to submit your application as soon as possible.

For questions regarding the position, please contact QA Team Lead, Gitte Jacobsen at [email protected].

For HR-related questions, please contact HR Manager Rikke Tjustrup at [email protected].

About Magle Group

Magle Group has a solid history within life science and has grown through strategic acquisitions. Today, the group consists of several specialized entities, including Magle Biopolymers, with a strong focus on dextran technology and CDMO services.