Quality Control Specialist (Microbiology)

Job Description

Do you want to work for one of the largest industrial and pharmaceutical group in the Netherlands within a high-tech environment and use your knowledge and skills to produce products that matter and saves lives?

For our location in Oss Biotech we are looking for a Quality Control Specialist (Microbiology)

The Team

You will be joining the QCB team (Quality Control Biotech) with two lab analysts and the manager. We are responsible for setting up a laboratory for microbiology Quality Control. Try to avoid any contaminations within production. We will be growing because if we implement the new microbiology methods, we will also need additional people to perform and execute the tests.

Primary responsibilities

Quality strategy

• Initiate, develop and ensure implementation of knowledge, standards, procedures and guidelines. Strong collaboration with the global MAS Organization.
• Method development and implementation of rapid microbiological methods (e.g. 3P stations, KTA endotoxin, BacTALERT and Milliflex Quantum), including implementation of Digital Lab Records (DLR).
• Writing and review of technical documents to support regulatory filings.
• Management of third party organizations (CLO).
• In co-operation with functional areas and in line with quality procedures and guidelines, supports the handling of deviations, including implementation of CAPA’s.
• Ensures quality concerns and/or opportunities are presented to management and/or project teams for prompt resolution.
• Participates and leader in improvement projects, root cause investigations and trouble shooting.

Compliance

• Responsible for initiating, revising and monitoring lab procedures to ensure all is in compliance.
• Participates in site/ corporate audits, and regulatory inspections including support to audit/ inspections responses as microbiological Subject Matter Expert (SME).
• Tracks the overall status of all quality systems assigned (Changes, CAPAs, QMS, changes) assuring completion with the due date and in compliance with our QMS and regulations.
• Participates in Quality Area projects to develop and implement improved/lean processes.
• Identifies opportunities for improvement.
• Communicates any major or critical observations to management for proper immediate, interim and final action(s) to be taken to reach compliance.
• Evaluates and approves changes assuring they are in compliance with applicable SOP’s, quality manual, products market filing, and qualification (as applicable) and are closed with all the supporting documentation.
• Sub System Owner or SME of a QMS chapter for the site

Guidance

• Microbiological project management and participation in cross-functional/global teams
• Guide the functional area on quality issues and ensure implementation of quality related improvements, procedures and guidelines

Administrative

• Assures that raw data are documented, reviewed and approved in DLR and GLIMS
• Provides supports for QNs, follow up on QNs, CAPAs and Change Control

Problem solving

• Provides day to day support for our Biotechnology Operations Oss, raising concerns if needed or directing users to do so. Partner with relevant internal and global groups (e.g. MAS and MRL) for building, maintaining and sharing knowledge and information

EHS Responsibility

• Responsible for actively contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.
• Involved and leader in Management of Changes (MOC’s)

Your profile

• Bachelor’s degree required, preferably in Microbiology, Biology or related field.
• Around 3-5 years of relevant experience in the pharmaceutical industry
• Advanced proficiency and/or knowledge of rapid microbiological methods (3P stations, KTA endotoxin, BacTALERT and Milliflex Quantum) is a plus.
• Good knowledge and experience with GMP (Good Manufacturing Practice);
• Good knowledge and experience with GDP (Good Documentation Practice) and LIMS (laboratory Information Management system);
• Strong projectmanagement skills;
• You have experience in writing protocols and reports.
• Hands-on mentality, proactive and flexible.
• Accurate, quality and service oriented.
• Good oral and written skills in Dutch and English.

We offer

Working at our organization means working together on health in an international working environment with dedicated colleagues. You will be given all the space you need to develop yourself and show who you are. You can also count on attractive terms of employment:

• A competitive salary.
• 35.5 vacation days.
• 8% holiday allowance and 3% end-of-year bonus.
• Annual Incentive Plan.
• An excellent pension.
• Reimbursement
• Various training modules.

About our organisation

Today, our organization is a global leader in health care and contributes to a healthy world. Through our medicines, vaccines, biologics and support services, we provide innovative treatments for better human and animal health in more than 140 countries. We are actively involved in improving access to health care. We do this through comprehensive policies, programmes and partnerships. Our organization in the Netherlands employs approximately 4500 employees at three different main locations: Oss, Haarlem and Boxmeer.

At our organization Biotech Operations in Oss, medicines are made for women who do not become pregnant naturally (IVF). Up Stream Processing (USP) is the Biotech department where these drugs are made by living cells in special breeder reactors. They are then purified in Down Stream Processing (DSP) in order to be able to administer them as medicines.

The factories run continuously in cleanroom environments and have some large projects to introduce new medicines. For this purpose, the departments have three production buildings and breeder reactors ranging from 10 to 20,000 litres. USP and DSP both have a separate Maintenance and Reliability department that takes care of maintenance and department-related investment projects on a day shift. The production facility is high-tech and modern.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R277573