Assoc. Specialist Analytical Method Validation, Quality Control

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

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.

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:

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