Job Description
Senior Technician, Quality
Purpose of the role
The purpose of this role is to ensure the quality, compliance, and continuous improvement of incoming materials and manufacturing processes. This includes reviewing and releasing incoming goods, managing deviations and investigations, supporting CAPAs and change controls, maintaining GMP‑compliant documentation, and collaborating with internal and external partners such as Contract Laboratories and suppliers. The role also contributes to process improvements, quality oversight, and compliance with safety, health, and environmental policies, while providing day‑to‑day quality support to Biotechnology Operations
Main responsibilities
- Executes reviews of incoming goods records and performs all related actions in supporting systems such as SAP.
- Releases incoming materials and chemicals in accordance with established quality requirements.
- Conducts IC&SM investigations, impact assessments covering product, process and validation aspects, performs Root Cause Analyses, and prepares investigation protocols and deviation reports.
- Collaborates with functional areas to ensure effective deviation handling and supports the implementation of CAPAs.
- Manages and supports changes related to incoming materials, including writing, updating, and maintaining compliant documentation.
- Ensures all area documentation is completed according to site SOPs, company guidelines, procedures, and applicable regulatory requirements.
- Identifies and escalates quality concerns or improvement opportunities to management or relevant project teams to ensure timely resolution.
- Maintains communication with Contract Laboratories and manages supplier complaints.
- Provides data to support the PQR process and participates in improvement initiatives.
- Initiates, revises, and monitors area procedures to ensure compliance and supports Quality Area projects aimed at implementing improved and lean processes.
- Identifies opportunities for optimization and communicates major or critical observations to management for appropriate immediate and long‑term action.
- Acts as change owner for document changes and ensures accurate documentation, review, and approval of raw data.
- Supports QNs and follows up on QNs, CAPAs, and Change Controls. Provides daily quality support to Organon Biotechnology Operations Oss, raising concerns or directing users appropriately.
- Collaborates with internal and global partners, including Organon, FDA, and EMEA, to share, build, and maintain knowledge and ensure alignment.
- Actively contributes to the realization of corporate policies on safety, health, and environment, demonstrating personal commitment to safe, healthy, and environmentally responsible working practices.
Your profile
- A Senior Secondary Professional Education (MLO) background in a scientific discipline with over 5 years of experience in the pharmaceutical industry and working under cGMP, or a bachelor’s degree (HLO) in Biotechnology, Chemistry, or a related field with more than 3 years of relevant pharmaceutical and cGMP experience.
- Experience in an Analytical Laboratory is required.
- Demonstrates a continuous learning mindset, preferably with familiarity in MPS/Lean Six Sigma.
- Possesses basic knowledge of the Organon Biotechnology Operations Oss Quality Management System, quality and compliance guidelines, and fundamental technical understanding of analytical testing techniques.
- Shows strong planning capabilities, solid computer literacy, and experience with documentation systems and SAP (preferred).
- Has strong client focus, works effectively both independently and as part of a team, and brings excellent written and verbal communication skills in Dutch and English.
- Displays a passion for continuous improvement and is skilled in deviation management, including Root Cause Analysis and technical writing.
We offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
- Competitive salary and a 3% year-end bonus.
- 35,5 days of leave.
- Attractive collective health care insurance package with considerable reduction rates.
- Solid Pension Plan.
- Incentive Plan (bonus).
- Commuting allowance.
- Numerous training, coaching and e-learning modules for long term job opportunities and development.
With Organon, your career is more than just a job — it’s a journey of purpose, impact, and leadership. Together, we are building innovative solutions that improve health and change lives around the globe. If you're ready to grow, lead, and be part of something bigger — we want to hear from you!
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1