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Sr. Spclst, External Quality

5+ years
Not Disclosed
10 Nov. 24, 2024
Job Description
Job Type: Full Time Education: MS/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science/BS 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 a Quality Assurance (QA) Specialist position at Organon. Below is a detailed breakdown of the key aspects of the role:

Position Overview:

  • Accountable for: Ensuring that all company products managed by External Quality Assurance (EQA) meet regulatory and internal quality requirements. The role includes oversight of manufacturing, packaging, testing, release, storage, and distribution at both the company’s facilities and external entities (EE).

Key Responsibilities:

  1. Compliance and Regulatory Oversight:

    • Ensure adherence to company policies/procedures and all applicable regulatory requirements (e.g., GMP).
    • Approve changes to master batch records or laboratory methods/specifications.
    • Release products ensuring that they comply with all regulations and internal procedures.
  2. Metrics and Process Improvement:

    • Compile, analyze, and report metrics to identify trends or root causes for process improvements.
    • Accountable for the oversight of products produced or tested at External Entities (EE), ensuring they meet quality and regulatory standards.
  3. Quality Control and Documentation:

    • Oversee product testing and review batch documentation, including investigating deviations.
    • Ensure quality controls are in place for all stages of the product lifecycle, including oversight of product testing.
  4. Safety Compliance:

    • Operate in a safe and efficient manner, ensuring adherence to safety policies.
  5. Travel Requirements:

    • The role requires up to 25% travel, occasionally on short notice.

Preferred Education, Experience, and Skills:

  • Education: A minimum of a 4-year degree in a relevant field (e.g., Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent).
  • Experience:
    • At least 5 years of experience in the pharmaceutical industry and quality management.
    • At least 3 years of experience in sterile manufacturing and quality management.
  • Skills:
    • Strong interpersonal, communication, coaching, and negotiation skills to build relationships.
    • Ability to work collaboratively across boundaries with leadership skills.
    • Fluent in English, both written and verbal.
    • Prior management experience is preferred.
    • Moderate understanding of contractual and financial aspects.
    • Previous experience with regulatory inspections.
    • Familiarity with domestic and foreign regulations governing plant operations.

Additional Information:

  • Employee Status: Regular, full-time position.
  • Relocation: No relocation support is provided.
  • VISA Sponsorship: Not provided.
  • Travel: Up to 25% travel required.
  • Flexible Work Arrangements: Not specified.

Organon Overview:

  • Organon is a global healthcare company focusing on improving health outcomes, especially for women and their families. Their portfolio spans women’s health, biosimilars, and other health solutions.

Would you like assistance in preparing a cover letter or resume for this position, or is there any other specific information you need about the role?