Assoc. Specialist Analytical Method Validation, Quality Control

Organon LLC; Oss; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Year-end bonus

Leave allowance

Health insurance

Pension plan

Incentive bonus

Commuting allowance

Training & development

Job summary

Organon LLC in Oss invites an Assoc. Specialist Analytical Method Validation (AMV) to ensure quality control testing readiness and to lead validation projects from protocol to report.

You will train staff, mentor interns, and act as SME for analytical methods, driving continuous improvement while complying with GxP and safety standards in a global healthcare setting.

Qualifications

• Bachelor's degree in Analytical Chemistry or a related field.
• Strong communication and interpersonal skills.
• Able to work independently, make decisions, and demonstrate a critical and accurate approach.
• Excellent command of Dutch and English, written and spoken.
• Strong training, coaching, and knowledge-transfer skills.
• Ability to effectively manage continuously changing priorities.
• Hands-on mentality with a flexible and proactive attitude.
• Results oriented, accurate, quality-focused, and customer/service-oriented.
• Minimum of 5 years of experience working in an analytical laboratory environment.
• Experience with analytical method validation and verification is highly desirable.
• Serves as an analytical/technical SME with extensive theoretical and practical knowledge of all analytical methods and techniques used within the team's scope of responsibility.

Responsibilities

• Ensure continuity of operational activities in the absence of the Laboratory Manager.
• Coordinate workflow and manage priorities to ensure all testing activities are completed and reported within the required timelines.
• Execute, review, and approve validation and verification activities.
• Initiate, coordinate, and oversee analytical method validation projects.
• Prepare validation protocols and validation reports.
• Review and approve analytical results, protocols, and reports.
• Occasionally perform analytical testing, depending on team capacity and operational priorities.
• Initiate and coordinate analytical changes as Change Owner.
• Conduct scientific investigations and studies.
• Participate in a Subsystem as an analytical/technical SME.
• Assess, investigate, and follow up on deviations.
• Initiate and coordinate CAPAs.
• Interpret data, results, and trend analyses, draw conclusions, and initiate follow-up actions where required.
• Provide scientific and technical justification and documentation for atypical results, trends, or deviations as a technical SME.
• Train laboratory personnel in quality control procedures and protocols.
• Supervise and mentor interns.
• Contribute to the continuous improvement of quality control processes and procedures.
• Stay informed of developments within the field of expertise, proactively make recommendations, and establish and maintain relevant internal and external networks.
• Respond to questions during internal and external audits.
• Comply with GxP requirements and regulations related to safety, hygiene, and environmental standards.
• Continuously identify opportunities to improve efficiency and reduce waste within laboratory processes and procedures.

Skills

Strong communication

Independent decision making

Dutch/English proficiency

Training/knowledge transfer

Prioritization

Hands-on mentality

Results oriented

Analytical lab experience 5+ years

Analytical method validation

Subject Matter Expert (SME)

Education

Bachelor's degree (HBO) in Analytical Chemistry or related field

Job description

Job Description Assoc. Specialist Analytical Method Validation (AMV), Quality Control

Responsibilities

• Ensure continuity of operational activities in the absence of the Laboratory Manager
• Coordinate workflow and manage priorities to ensure all testing activities are completed and reported within the required timelines
• Execute, review, and approve validation and verification activities
• Initiate, coordinate, and oversee analytical method validation projects
• Prepare validation protocols and validation reports
• Review and approve analytical results, protocols, and reports
• Occasionally perform analytical testing, depending on team capacity and operational priorities
• Initiate and coordinate analytical changes as Change Owner
• Conduct scientific investigations and studies
• Participate in a Subsystem as an analytical/technical Subject Matter Expert (SME)
• Assess, investigate, and follow up on deviations
• Initiate and coordinate Corrective and Preventive Actions (CAPAs)
• Interpret data, results, and trend analyses, draw conclusions, and initiate follow-up actions where required
• Provide scientific and technical justification and documentation for atypical results, trends, or deviations as a technical SME
• Train laboratory personnel in quality control procedures and protocols
• Supervise and mentor interns
• Contribute to the continuous improvement of quality control processes and procedures
• Stay informed of developments within the field of expertise, proactively make recommendations, and establish and maintain relevant internal and external networks
• Respond to questions during internal and external audits
• Comply with GxP requirements and regulations related to safety, hygiene, and environmental standards
• Continuously identify opportunities to improve efficiency and reduce waste within laboratory processes and procedures

Required Education, Experience, and Skills

• Bachelor's degree (HBO) in Analytical Chemistry or a related field
• Strong communication and interpersonal skills
• Able to work independently, make decisions, and demonstrate a critical and accurate approach
• Excellent command of both Dutch and English, written and spoken
• Strong training, coaching, and knowledge-transfer skills
• Ability to effectively manage continuously changing priorities
• Hands‑on mentality with a flexible and proactive attitude
• Results-oriented, accurate, quality-focused, and customer/service-oriented
• Minimum of 5 years of experience working in an analytical laboratory environment
• Experience with analytical method validation and verification is highly desirable
• Serves as an analytical/technical Subject Matter Expert (SME) with extensive theoretical and practical knowledge of all analytical methods and techniques used within the team's scope of responsibility

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.

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.

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.