Quality Assurance Analyst

3 maanden geleden

Leiden, Nederland ClinChoice Voltijd

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice, is searching for a Freelance Quality Assurance Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, initially on a 12 month contract. This is a hybrid role, with 3 days from the office in Leiden, and will be for 1 FTE, although 0.8 FTE will also be considered.

The Quality Assurance Analyst will be responsible for configuring the Laboratory Information Management System (LIMS) to the laboratory needs, following documented specifications and protocols. You will play an important role in translating testing requirements into LIMS configuration. As a LIMS specialist you act as a bridge between the product managers, laboratory technicians and the LIMS system.

**Main Job Tasks and Responsibilities**:

- Responsible for the translation of technical documents into LIMS requirements.
- Responsible for configuring the LIMS for testing.
- Acts as a bridge between the product managers and the LIMS.
- Acts as a liaison between the technicians and the LIMS.
- Solving (ad hoc) LIMS problems as they arise.

**Education and Experience**:

- Minimum Bachelor's degree in Life Sciences or Computer Sciences.
- Minimal 2 years of work experience in Pharma with GMP and automation skills.
- Strong knowledge and experience with LIMS Laboratory Experience is a plus.
- Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships.
- Proficiency in written and oral English, with a desirable command of Dutch.

**Specific Role Requirements and Skills**:

- Excellent planning skills and the ability to prioritize multiple commitments.
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence and procedures.

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**Key words**: Quality Assurance Analyst, Quality Assurance, GMP, CAPA, LIMS, Lean, Six Sigma, Laboratory, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

LI-CM1 #LI-HYBRID #CONTRACT

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