Technical Specialist - QA - Lab Testing - Pharmaceuticals

TECHNICAL SPECIALIST - LEIDEN, NETHERLANDS/6 MONTHS CONTRACT/38 TO 44 EUR (PER HOUR)

JOHNSON & JOHNSON IS AN AMERICAN MULTINATIONAL MEDICAL DEVICES, PHARMACEUTICAL AND CONSUMER PACKAGED GOODS MANUFACTURER FOUNDED IN 1886.

Are you university (WO) graduated? Do you have demonstrable experience and affinity with analysis methodology in combination with laboratory instruments? Do you have the ambition to develop yourself as a (Senior) Technical Specialist in an international biotechnology company?

This job at the One Lab Laboratories at Janssen Biologics B.V. will give you a wonderful opportunity!

The One Lab Laboratories is a combined lab existing out of several test labs.

The specified test labs are divided based on specific techniques and/or expertise.

All test labs are supported by a Lab Service team. The Lab Service team consists out of specialized sub teams: Automation, Change Control & Deviations, Compliance and Equipment Life Cycle Management.

THE SPECIALIST:

- Plans, schedules, coordinates, tracks and prioritizes all facets of buying, installing and validating (new) lab equipment, also directs, supports and oversees testing efforts, executes protocols for installation, operational and performance qualification testing, reviews data, generates documentation and reports.
- Interacts with contract manufacturers.
- Performs, coordinates and assists in various quality functional areas and maintains expertise. Conducts investigations, collects data, analyzes trends and prepares reports for assigned quality processes. Has thorough understanding of process criteria and regulations and business impact of decisions and actions, ensures and maintains a state of inspection readiness.
- Provides quality support for technology transfer and improvement of existing laboratory processes.
- Provides (standard) definitions, develops and establishes quality and data integrity expectations and ensure compliance to those expectations.
- Improves the quality of systems processes and standards on the site (leverage on existing and implement new technologies).
- Translates user requirements into technical specifications and systems following the set DI standards.
- Makes proposals, writes and assists in CAPA plans and Change Controls, owns, monitors and gives follow up on the implementation and closure of the documentation steps.

QUALIFICATIONS AND COMPETENCES:

- Master's degree in Life Sciences, analytical chemistry, bio chemistry, or comparable
- Project management skills and interpersonal skills, engaged in contact with personnel at all levels within and outside the organization.
- Written and oral communication skills in English. Dutch is desirable.
- Planning skills, ability to prioritize multiple commitments.
- Take the leadership role to coordinate the initiatives and to ensure deliverables are met amongst the different site departments without hierarchical context.
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro Active, works independently, takes actions in the absence of specific instruction and can write protocols/reports, business correspondence and procedures

IF YOU MATCH THESE REQUIREMENTS, PLEASE APPLY IN THE NORMAL WAY. ELEVATE WILL SEND YOU AN EMAIL, PLEASE OPEN, CLICK AND ACTION THAT EMAIL AND YOUR APPLICATION WILL BE VISIBLE TO THE HIRING ORGANISATION DIRECTLY.