The Company
The company is a global American women's health and fertility pharmaceutical pioneer.
Role Description
As an Associate Specialist in Microbiology within the Analytical Development Validation Microbiology team, you will play a key role in managing microbiological projects and studies across various departments. You will be involved in developing and executing microbiological analyses, performing root cause analyses in production environments, and supporting quality control microbiology teams. This dynamic role requires flexibility as you will be working on diverse tasks with changing priorities, interacting with multiple stakeholders, and ensuring the success of various projects within the organization.
Responsibilities
- Developing and executing method suitability for conventional microbiological analyses, ensuring accurate reporting and documentation.
- Independently coordinating and lead projects, including the execution and reporting of microbiological studies related to specific products.
- Performing and leading root cause analyses within the production environment in Oss, as well as in the QC-M lab, and managing deviations (ETQ).
- Maintaining up-to-date knowledge of microbiological analysis techniques and trends.
- Serving as a subject matter expert during audits and inspections.
- Planning and executing work to ensuring the achievement of agreed timelines and goals.
- Participating in Quality Risk Assessments and contributing to identifying potential risks.
- Providing microbiological knowledge transfer and training to Quality Control Microbiology and various production departments.
- Continuously expand knowledge of strategies and practices.
Requirements
- A completed higher vocational education (HBO) in Microbiology.
- Preferably 3-5 years of experience in a pharmaceutical process environment and microbiological lab.
- Experience with GMP and GDocP (Good Documentation Practice).
- Hands-on approach with a proactive and flexible attitude.
- Detail-oriented, quality- and service-driven.
- Ability to take responsibility and initiative in a fast-paced environment.
- Strong ability to work independently and as part of a team.
- Goal-oriented, stress-resistant, and capable of managing multiple projects with shifting priorities.
- Proficient in both written and spoken Dutch and English.
- Proven experience in leading and coordinating projects, as well as writing protocols and reports.
- Strong problem-solving skills and a positive, constructive attitude.
- Ability to manage diverse projects, deadlines, and challenges effectively.
- Availability for the next 6 months.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
54630
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
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