Technician, QA Manufacturing Support

AGC Biologics; København; In loco; DKK 550.000 - 750.000; Tempo pieno

Descrizione del lavoro

AGC Biologics in Søborg seeks a QA Manufacturing Support Technician to stay close to production and help ensure GMP-compliant documentation for batch releases. You will review Batch Production Records and Solution Preparation Sheets and support the solution preparation suite.

You will print and manage Batch Process Records, assist with labeling, and provide real-time QA oversight on the production floor while collaborating with Manufacturing and QA to maintain compliant operations.

Competenze

• Bachelor's degree or Technician in production; GMP/GLP environment experience preferred.
• Experience in GMP or GLP production environment or QA department in biopharma.
• Experience reviewing Batch Production Records and Solution Preparation Sheets.
• Strong communication and collaboration with cross-functional stakeholders.

Mansioni

• Perform QA Oversight in the Solution Preparation production suite.
• Support manufacturing during review of batch documentation and Good Documentation Practice questions.
• Review and approve Buffer and Media Batch Production Records.
• Print Batch Process Records and manage manufacturing labels.
• Provide real-time review of manufacturing records and logbooks.
• Assist with scanning, archiving and related activities as needed.

Conoscenze

Strong communication & collaboration

Fluent English (written and spoken)

Formazione

Bachelor's degree (BSc) or Technician in production

Descrizione del lavoro

QA Manufacturing Support Technician

Be close to production and make a difference in quality every day

At AGC Biologics in Søborg, Quality and Manufacturing go hand in hand. As our new QA Manufacturing Support Technician, you will play an important role in supporting manufacturing activities during solution preparation and ensuring that production documentation meets GMP requirements.

This position offers an exciting combination of working close to the production line and handling batch record reviews and buffer and media documentation. You will be an important link between QA and Manufacturing, helping to connect the two functions and support a smooth and compliant manufacturing process.

Where Quality meets Manufacturing

In this role, you will support the Manufacturing Batch Release process by ensuring that solution (media and buffers) batch documentation are reviewed in accordance with established procedures and GMP requirements.

Your daily responsibilities will include:

• Performing QA Oversight in the Solution Preparation production suite in VAT83B.
• Supporting manufacturing during review of batch documentation, including questions related to Good Documentation Practice.
• Reviewing and approving Buffer and Media Batch Production Records.
• Printing Batch Process Records and managing manufacturing labels.
• Providing real-time review of manufacturing records and logbooks.

You may also support scanning, archiving and other related activities when needed.

What makes this position particularly interesting is the opportunity to combine documentation review with direct interaction with production. You will be close to daily manufacturing activities while contributing to the Quality processes that support batch release.

A dynamic team with strong connections to production

You will become part of a dynamic and proactive QA team consisting of 7 Scientists and 4 Student Assistants.

The team works closely with Manufacturing, and collaboration is an important part of everyday work. Together with your manager and colleagues, you will help build strong connections between QA and Manufacturing, acting as a bridge between the teams.

This is a role for someone who enjoys being involved in daily operations, working with different colleagues and combining structured documentation tasks with close collaboration on the production floor.

Bring your attention to detail and collaborative mindset

We imagine that you hold a Bachelor's degree (BSc) or a qualification as a Technician in production. Ideally, you have experience from a GMP or GLP production environment or a QA department within the biopharmaceutical industry.

You bring an interest in, or previous experience with, reviewing Batch Production Records and Solution Preparation Sheets.

Strong communication and collaboration skills are important, as you will work with colleagues and stakeholders across functions. You are fluent in written and spoken English and communicate clearly with both internal and external stakeholders.

As a person, you have a positive mindset, are flexible and enjoy taking on new tasks and responsibilities. You thrive in a dynamic environment and are comfortable navigating uncertainties.

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world's most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.