Assoc. Specialist Analytical Method Validation, Quality Control

Biopharma Careers; Netherlands; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

3% year-end bonus

35.5 days leave

Health insurance package

Pension plan

Incentive plan (bonus)

Commuting allowance

Training and development modules

Job summary

Organon seeks an Assoc. Specialist Analytical Method Validation (AMV) to coordinate and prioritize lab activities, ensure timely testing and reporting, and review analytical results and validation protocols.

The role may involve executing analytical testing as needed and serving as a SME for analytical methods within the team. The ideal candidate will have a HBO Bachelor’s in Analytical Chemistry, strong Dutch and English communication, and at least 5 years’ laboratory experience with method

Qualifications

• Bachelor's degree in Analytical Chemistry or a related field is required.
• Strong communication and interpersonal skills.
• Able to work independently and make decisions with a critical and accurate approach.
• Excellent command of Dutch and English, written and spoken.

Responsibilities

• Coordinate and prioritize operational activities to ensure timely testing and reporting.
• Review and approve analytical results, and prepare (validation) protocols and reports.
• Execute, review, and approve validation and verification activities; participate in analytical testing when needed.
• Act as SME for analytical methods and techniques; train staff and mentor interns.
• Support continuous improvement of QC processes and ensure compliance with GxP and safety standards.

Education

Bachelor's degree in Analytical Chemistry

Job description

Job Description

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

The Associate Specialist Analytical Method Validation (AMV) is responsible for coordinating and prioritizing operational activities, ensuring the timely execution and reporting of testing activities within the required timelines. In addition, the Associate Specialist Analytical Method Validation (AMV) is responsible for reviewing and approving analytical results, as well as preparing and reviewing (validation) protocols and (validation) reports. Depending on team capacity and operational priorities, the execution of analytical testing may occasionally form part of the role's responsibilities.

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

• 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.

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: Domestic

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