Quality Assurance Specialist, Document Controller - Basel

☞ Moderna

View: 208

Update day: 26-03-2024

Location: Basel Basel-Stadt BS

Category: Administrative / Clerical / Assistant

Industry: Financial Services Biotechnology Pharmaceuticals

Position: Director

Job type: Full-time

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Job content

The Role

The Quality Assurance (QA) Specialist, supporting Document Control is responsible for the maintenance of document control in compliance with business needs and regulatory expectations. The individual is responsible for formatting and administration of all applicable electronic document workflows and acts as an SME for all Document Control related questions from the business. This role will also be responsible for periodic review of GMP documentation.

Here’s What You’ll Do
  • Primary SME for Document control related questions
  • Support cross functional teams in processing document requests, approval, changes and certification
  • Ensure documentation is processed, formatted, issued, and made effective accurately
  • Perform document periodic review process; track, monitor, work with area owners/SMEs per schedule
  • SME for Electronic documentation management systems (EDMS)
  • Perform other projects related to improvement of quality systems as needed and required by management
  • Generate Document Control metrics for all sort of Management reviews and Dashboards
  • Update Document Control procedures and training material as needed.
  • Assist in Document Control process improvements with Document Types, Lifecycles, and Workflows
Here’s What You’ll Bring To The Table
  • As minimum, we are seeking for candidates to possess a Bachelors’ Degree as well as 2+ years’ of relevant work experience
  • Experience in document control in biotech or related regulated industry is highly preferred
  • Strong verbal and written English communication skills (additional language skills are advantageous) – you are outgoing, communicative, and seek to build relationships on a daily basis.
  • You drive for results and set a high bar for yourself and others
  • A nature ability to be organized in how you think, communicate and conduct your work
  • A ‘digital first’ mindset
  • A curious mindset that allows you to constantly learn and challenge the status quo
  • Respect for others and a desire to work as a team. We win together.
  • Strong Excel skills and solid experience with PowerPoint and Word.
  • A spirit of optimism, positivity and ‘anything is possible’ mindset.
  • Sense of humor and ability to be flexible in a fast-paced environment
About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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Deadline: 10-05-2024

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