Novartis

Quality Specialist, Batch Disposition

Novartis

Cambridge, MA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

"Are you a detail-oriented and meticulous individual with a passion for ensuring the highest quality standards in pharmaceutical products? Novartis is seeking a dedicated Quality Specialist to join our team as a Batch Disposition expert. As a key member of our Quality Assurance department, you will play a crucial role in the release and disposition of batches, ensuring compliance with regulatory requirements and company standards. If you have a strong understanding of GMP principles, excellent communication skills, and an unwavering commitment to quality, we want to hear from you!"

  1. Review and evaluate batch records to ensure compliance with regulatory requirements and company standards.
  2. Make informed and timely decisions on the release and disposition of batches based on quality data and documentation.
  3. Conduct thorough investigations of any quality issues or deviations, and work with cross-functional teams to implement corrective and preventive actions.
  4. Collaborate with manufacturing and supply chain teams to ensure timely release of batches and efficient flow of product.
  5. Develop and maintain strong knowledge of GMP principles and regulatory guidelines to ensure compliance in all batch disposition activities.
  6. Participate in internal and external audits, providing necessary documentation and support to auditors.
  7. Communicate effectively with internal stakeholders and external partners regarding batch disposition status and any quality issues.
  8. Monitor and track batch disposition metrics, identifying trends and areas for improvement.
  9. Continuously evaluate and improve batch disposition processes to ensure efficiency and compliance.
  10. Train and mentor other team members on batch disposition processes and procedures.
  11. Maintain accurate and organized documentation of all batch disposition activities.
  12. Adhere to all safety protocols and procedures while handling and disposing of pharmaceutical products.
  13. Stay up-to-date with industry developments and changes in regulations related to batch disposition and quality assurance.
  14. Serve as a subject matter expert and resource for all batch disposition related inquiries and issues.
  15. Collaborate with other departments to implement quality improvement initiatives and ensure consistent quality standards across the organization.
Where is this job?
This job is located at Cambridge, MA, USA
Job Qualifications
  • Bachelor's Degree In A Scientific Field Such As Chemistry, Biology, Or Pharmacy.

  • Minimum Of 3-5 Years Of Experience In Quality Assurance Or Quality Control In A Pharmaceutical Or Biotechnology Industry.

  • Knowledge Of Cgmp Regulations And Guidelines, As Well As Experience With Regulatory Inspections.

  • Strong Attention To Detail And Ability To Analyze And Interpret Data To Make Critical Decisions.

  • Excellent Communication And Interpersonal Skills, With The Ability To Work Collaboratively With Cross-Functional Teams.

Required Skills
  • Risk Management

  • Quality Assurance

  • Data Analysis

  • GMP

  • Quality Systems

  • Auditing

  • Batch

  • Root Cause Analysis

  • Regulatory compliance

  • Documentation management

  • SOP Development

  • Batch Release

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Quality Specialist, Batch Disposition in Cambridge, MA, USA is $60,000 to $90,000 per year. This salary range can vary depending on factors such as experience, qualifications, and the specific company or industry. Some companies may also offer additional benefits, bonuses, and incentives as part of their compensation package for this role.

Additional Information
Novartis is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedApril 22nd, 2024
Apply BeforeApril 11th, 2026
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About Novartis

Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.

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