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    Senior Analyst, Qa

    Novo Nordisk
    5+ years
    Not Disclosed
    Bloomington Remote United States
    10 Feb. 13, 2025
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Job Title: Senior Analyst, QA
    Location: Bloomington, United States
    Job Category: Quality

    The Position

    The Senior Analyst, QA plays a critical role in leading and managing quality investigations, ensuring compliance with cGMPs, and working with cross-functional teams to resolve deviations. The position requires strong leadership, problem-solving abilities, and a deep understanding of regulatory standards. The role involves performing investigations, developing corrective and preventative actions (CAPAs), and mentoring team members.

    Relationships

    • Reports to: Caleb Buuck

    Essential Functions

    • Deviation Investigations & Root Cause Analysis:

      • Lead multi-functional teams to troubleshoot deviations and identify root causes.
      • Review deviation triage and Risk Priority Number (RPN) classification to ensure alignment with company standards.
      • Collaborate with the Quality unit to resolve discrepancies in deviation classification.
      • Work with the team to define the problem and focus investigations on the critical aspects of the issue.

    • Investigation Management & CAPA:

      • Conduct interviews to gather data and present findings that support root cause identification and product impact conclusions.
      • Develop investigation hypotheses and guide the team through the root cause analysis.
      • Prioritize corrective actions, focusing on engineering solutions first before considering administrative controls.
      • Complete comprehensive deviation reports, including facts and evidence that lead to actionable CAPAs.
      • Present investigation summaries and CAPAs for approval from the deviation review board.
      • Follow up on CAPA effectiveness and address any repeat deviations.

    • Leadership & Mentorship:

      • Mentor investigators and assist with their professional development.
      • Lead team meetings and huddles to ensure timely closure of major deviations (minimum of 10 per month).

    Physical Requirements

    • Frequent sitting, standing, walking, reading, and use of a computer monitor.
    • Occasional stooping, kneeling, crouching, carrying, and grasping.
    • Ability to work in a clean room environment as needed.
    • Must comply with EHS responsibilities for the position.

    Qualifications

    Education/Experience:

    • Required:
      • Bachelor’s degree in a STEM discipline.
      • 5-8 years of experience in a regulated industry, with at least 2 years in GMP.
    • Preferred:
      • Master’s degree or higher.

    Technical Skills:

    • Proficiency in Excel, Word, and other office software.
    • Experience with scientific and quality management systems (e.g., TrackWise®, ComplianceWire®, JD Edwards®).
    • Strong understanding of cGMP regulations and clinical/commercial operations.
    • Experience in leading deviation investigations using root cause analysis.
    • Ability to analyze trends, interpret data, and suggest solutions.
    • Knowledge of risk assessment tools (e.g., FMEA, QCA) and change control.

    Behavioral Requirements

    • Ability to communicate clearly in English and follow instructions.
    • Strong time management skills and the ability to meet deadlines.
    • Detail-oriented and organized with the ability to handle multiple tasks under pressure.
    • Ability to mentor and transfer knowledge to others effectively.
    • Strong problem-solving and critical thinking skills.
    • Sense of urgency in driving investigations to completion.
    • Collaborative and solution-oriented approach with SMEs.
    • Strong leadership and team-building skills, with the ability to drive actions and follow up on progress.

    Leadership Requirements

    • Lead by example, aligning with the company’s values and culture.
    • Build strong relationships with peers and team members.
    • Take initiative for personal development and address any scope or procedural issues.
    • Earn trust and respect from colleagues and stakeholders.

    Commitment to Diversity & Inclusion

    At Novo Nordisk, we are committed to creating an inclusive culture that celebrates the diversity of our employees, patients, and communities. We believe that diverse perspectives contribute to our success in life-changing work.

    Novo Nordisk is an Equal Opportunity Employer.
    Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

    If you require special assistance or accommodations to apply, please contact us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

    This structure clearly outlines the role, responsibilities, and qualifications for the Senior Analyst, QA position, making it easier for applicants to understand the key aspects of the job.

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