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Lab Manager, Quality Control (Emc)

5+ years
Not Disclosed
10 Nov. 24, 2024
Job Description
Job Type: Full Time Remote Education: HLO/WO Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description you provided is for the position of Lab Manager, Quality Control (EMC) at Organon in Oss, Netherlands, within the Quality Control Analytical Chemistry (QC-AC) department. The role involves overseeing laboratory equipment, managing projects related to equipment maintenance and improvements, and ensuring data integrity on the site. Here's a detailed breakdown of the position:

Position Overview:

  • Role: Laboratory Equipment Manager, Quality Control (EMC)
  • Department: Quality Control Analytical Chemistry (QC-AC)
  • Location: Organon site in Oss, Netherlands
  • Reports to: QC-AC Manager
  • Team Size: 10 to 15 people
  • Key Focus: Ensuring the reliability of laboratory equipment, managing technical projects, coordinating equipment maintenance, and supporting laboratory operations in compliance with GMP.

Key Responsibilities:

  1. Team Leadership:

    • Manage a team of 10-15 personnel.
    • Provide direction and leadership in the day-to-day activities of the team, ensuring operational efficiency and effectiveness.
  2. Equipment Maintenance & Improvement:

    • Develop and improve maintenance plans for laboratory equipment.
    • Identify opportunities for equipment improvements and write business cases for enhancement projects.
    • Lead or participate in projects involving equipment replacement and ensure proper documentation and planning.
    • Apply “Change control” procedures when implementing equipment changes.
  3. Project Management:

    • Manage technical projects related to laboratory equipment, including the replacement and qualification of equipment.
    • Monitor and report on the progress of ongoing projects to the QC-AC Manager and project team.
  4. Data Integrity:

    • Act as the Data Integrity Champion for the site, ensuring compliance with regulations and standards for data integrity in laboratory processes.
  5. Compliance and Quality:

    • Ensure that laboratory operations and equipment management meet GMP regulations and internal quality standards.
    • Maintain a strong focus on quality, compliance, and customer satisfaction.

Required Skills and Experience:

  • Education:
    • HLO/WO degree (higher vocational education/university level) with several years of relevant experience in analytical chemistry or a similar field.
  • Experience:
    • Experience working with laboratory equipment and within GMP regulations.
    • Strong ability to manage technical projects and improve operational efficiency.
    • Demonstrated leadership skills, including managing teams and driving improvements.
  • Skills:
    • Excellent communication skills in Dutch and English.
    • Proactive, with a focus on improvement and problem-solving.
    • Conceptual thinking with a strong focus on quality and compliance.
    • Business acumen in improving efficiency and effectiveness within operations.

Additional Information:

  • Employee Status: Regular, full-time position (100% employment).
  • Benefits:
    • Competitive salary and incentive plan.
    • 35.5 vacation days.
    • 8% vacation allowance and 3% year-end bonus.
    • Excellent pension plan.
    • Travel cost reimbursement.
    • Parental leave for both parents.
    • Various training modules for professional development.

About Organon:

Organon is a global healthcare company with a focus on improving women's health and well-being. The company operates in a diverse, international environment and is committed to innovation and improving health outcomes for women and families.


If you’re interested in applying or need assistance with tailoring a resume or cover letter for this position, feel free to ask!