Job Title: Microbiology Quality control engineer

Company: QVance AB, Huddinge, Sweden

About Us:

QVance is an innovative start-up focused on the provision of quality control (QC) analytics for the advanced therapy market. Developed by drug developers for drug developers the mission of the company is to be a one-stop shop for QC analytics, supporting developers across the full product lifecycle. We are committed to providing a personal service with bespoke support, helping developers from product inception through to commercialisation.

Position Overview:

We are seeking a Microbiology Quality Control Engineer to support our commitment to excellence in product quality and compliance within the advanced therapies sector. The ideal candidate will have a solid background in quality control processes, microbiology and a passion for improving healthcare outcomes through rigorous quality assurance practices.

Key Responsibilities:

·      Develop, implement, and maintain quality control procedures and protocols specific to advanced therapies.

·      Conduct routine microbiological testing for quality control for pharmaceutical production and release testing of drug products and raw materials.

·      Review and validate microbiological testing procedures and documentation.

·      Conduct thorough inspections and tests on products and processes to ensure compliance with regulatory standards and internal specifications.

·      Analyse quality data to identify trends, root causes of issues, and recommend corrective actions.

·      Comply to GMP practices in the work environment.

·      Collaborate with cross-functional teams including vendors to resolve quality issues and drive continuous improvement initiatives.

·      Participate in quality audits and inspections, ensuring adherence to Good Manufacturing Practices (GMP) and other relevant regulations.

·      Prepare detailed quality reports, documentation, and metrics for stakeholders.

·      Assist in the training and development of staff on quality control practices and methodologies.

·      To maintain equipment within the analytics laboratories according to GMP and in house quality standards.

·      To work directly with vendors and partners to ensure business continuity and business growth.

·      Stay updated on industry trends, regulatory changes, and advancements in quality control technologies.

Qualifications:

·      Bachelor’s degree in Microbiology, Life Sciences, Quality Assurance, or a related field; a Master’s degree is a plus.

·      3+ years of experience in quality control or assurance, preferably in the biopharmaceutical or advanced therapies industry.

·      3+ years of experience working in microbiology for pharmaceutical products, preferably advanced therapies.

·      Strong knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems.

·      Experience with data analysis tools and statistical methods.

·      Excellent problem-solving abilities and attention to detail.

·      Background working with advanced therapies in development or quality analytics.

·      Solution driven and self-motivated

·      Strong communication and interpersonal skills to effectively collaborate with various teams.

·      Fluent in English. Swedish or other Nordic language is considered to be an advantage.

What We Offer:

·      Competitive salary and pension.

·      A dynamic and inclusive work environment.

·      Opportunities for professional growth and development.

·      Private health insurance

·      Wellness package

·      Opportunity to join a company from its inception and help shape it for the future

How to Apply:

Interested candidates should submit their resume and a cover letter detailing their relevant experience through this link.

Please note this is a full time position, on site in Huddinge. Remote working is not possible as this is a laboratory based role.