QA Specialist - Environmental Monitoring

<p>Are you ready to make a difference in global health by ensuring the highest quality standards in vaccine production, contributing to the mission of saving lives?</p><p></p><p>As our QA Specialist in Environmental Monitoring (EM), you’ll operate in the delicate space between sterility and safety, between regulatory rigor and operational rhythm. You’ll be the eyes, ears, and conscience of our cleanroom environments — ensuring every product we release is made not only to spec, but in conditions that meet the highest standards of GMP compliance. You are not just performing checks. You are <u>preserving trust</u> — in every vial, every dose, every shipment.</p><p></p><p>If that caught your attention, then it’s amazing! We are looking for a QA Specialist – Environmental Monitoring for a 1 year parental cover position until the 30th of September 2026 for our Kvistgaard site, Denmark.</p><p></p><p><b>Boost our team</b></p><p><br/>The QA Operations organization consists of 38 employees, 5 managers, and the Head of QA Operations. You will be part of the dynamic QA-Environmental Team consisting of 3 colleagues. You will report to the Senior Manager for QA for Equipment Qualification and Environmental Monitoring section.  </p><p></p><p><b>What you’ll actually do</b></p><p></p><p>This position primarily focuses on:</p><ul><li>Review and approval of the Environmental Monitoring procedures and documentation e.g., trending, Deviations, CAPAs, Risk Assessments, Change Control, smoke studies, cleaning procedures</li><li>Handling of Out-of-Specification (OOS) and Laboratory Investigations</li><li>Investigate and report non-conformances or excursions; escalate issues that threaten product safety or compliance</li><li>Ensure GMP compliance by adhering to strict protocols, documentation practices, and aseptic techniques</li><li>Collaborate with other QA teams, QC Microbiology, Production, and Validation teams to drive continuous improvement and preventive action</li></ul><p></p><p><b>Are you our next pioneer?</b></p><p></p><p>We are not asking you to walk on water. This role isn’t for everyone. It’s for the detail-oriented, <span>contamination-fearing,</span> SOP and <span>compliance-respecting</span> quality QA mastermind who understand that compliance isn’t a suggestion — <u>it’s a lifestyle</u>.</p><p></p><p>Succeeding with our vision of becoming one of the largest pure-play vaccine companies in the world we need people like you who brings the following qualifications:</p><ul><li>+4 years of professional experience within a QA cGMP – regulated environment preferably from pharmaceutical, biotech, or medical devices industry</li><li>Min. MSc in Life Sciences, Microbiology or Engineering</li><li>Knowledge of QMS processes, Records Management, and Data Integrity is required</li><li>Experience in Inspection Readiness for audits by external parties</li><li>Proficiency in English</li></ul><p></p><p><b>Who are you?</b></p><ul><li>A team-first person – You know quality isn’t a solo mission — you work well with people from all departments and backgrounds</li><li>A people whisperer – Friendly, respectful, and confident enough to remind someone (for the third time) to fix their gowning technique — without making it weird</li><li>A strong communicator – You spot trends before they become problems, and you communicate them like a pro: clearly, kindly, and constructively</li><li>A calm force in a whirlwind – Whether it’s a minor excursion or a major audit, you stay cool, clear-headed, and constructive</li><li>A reliable – When it comes to compliance and consistency, your team knows they can count on you every time</li></ul><p></p><p><b>Why join us?</b></p><p></p><p>At Bavarian Nordic, we don’t just make vaccines — we make a difference. And while the world may never see the microbes you’re monitoring, they will definitely feel your impact. Join a team where "quality" isn't just a department — <u>it's a mindset</u>. Even our canteen follows GMP: <b>Great Meal Producing</b> — high-quality, consistently satisfying, and dangerously tasty food.</p><p></p><p>When you join us, you will be:</p><ul><li>Be part of a team that directly contributes to global health by manufacturing and developing life-saving vaccines, where your work here has a visible and significant impact</li><li>Surrounded by people who believe quality is everyone’s job, and you’re here to make it stronger</li><li>Given space to grow, contribute, challenge, and shape how we think about compliance and care</li><li>Encouraged to ask questions, challenge processes, and never settle for “just good enough”</li><li>Able to utilize charging stations for electric vehicles at our facilities in Kvistgaard</li><li>Accessing a convenient bus route (70E) from Humlebæk Station directly to our Kvistgaard facilities</li></ul><p></p><p><b>Ready to make a difference? Apply now!</b></p><p></p><p>If you have read this far and smiled at least once, you might just be the kind of quality assurance-driv