Catalent

Sr. Specialist, QA Batch Disposition

Catalent

Kansas City, MO, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Are you a highly skilled and experienced Quality Assurance professional looking for a new challenge? Look no further! Catalent is seeking a Sr. Specialist, QA Batch Disposition to join our team and ensure the quality and compliance of our pharmaceutical products. This crucial role requires a detail-oriented individual with a strong background in quality assurance and batch disposition. As a member of our team, you will have the opportunity to make a significant impact on the production and release process of life-saving medications. Join us and be a part of our mission to improve the health and well-being of patients worldwide.

  1. Ensure compliance with all relevant regulations and guidelines related to pharmaceutical quality and batch disposition.
  2. Perform batch disposition activities, including reviewing and approving batch records, certificates of analysis, and other relevant documentation.
  3. Conduct thorough quality reviews of batch production and testing data to ensure accuracy and consistency.
  4. Identify and investigate any quality issues or deviations and implement corrective and preventive actions.
  5. Collaborate with cross-functional teams to resolve quality-related issues and ensure timely release of products.
  6. Develop and maintain standard operating procedures (SOPs) for batch disposition and quality assurance processes.
  7. Conduct internal audits to assess compliance with quality standards and identify areas for improvement.
  8. Stay up-to-date with industry advancements and changes in regulations pertaining to quality assurance and batch disposition.
  9. Train and mentor junior team members on quality assurance processes and batch disposition activities.
  10. Drive continuous improvement initiatives to enhance the efficiency and effectiveness of quality assurance and batch disposition processes.
  11. Communicate with external stakeholders, such as regulatory agencies and suppliers, regarding quality-related matters.
  12. Maintain accurate and organized records of all quality assurance and batch disposition activities.
  13. Ensure timely and accurate reporting of quality metrics to management.
  14. Participate in cross-functional projects and provide quality assurance expertise and support as needed.
  15. Uphold the company's mission to improve the health and well-being of patients worldwide through the production of high-quality pharmaceutical products.
Where is this job?
This job is located at Kansas City, MO, USA
Job Qualifications
  • Bachelor's Or Master's Degree In A Relevant Scientific Field, Such As Pharmacy, Chemistry, Or Biology.

  • Minimum Of 5 Years Of Experience In Quality Assurance Or Batch Disposition Within The Pharmaceutical Or Biotech Industry.

  • Strong Understanding Of Gmp Regulations And Industry Standards, As Well As Experience With Regulatory Audits And Inspections.

  • Experience In Managing And Leading Cross-Functional Teams, As Well As Excellent Communication And Interpersonal Skills.

  • Proven Track Record Of Effectively Managing And Executing Batch Disposition Activities, Including Review And Approval Of Batch Records, Deviations, And Change Controls.

Required Skills
  • Quality Assurance

  • Problem Solving

  • Quality Systems

  • Auditing

  • Root Cause Analysis

  • Risk assessment

  • Regulatory compliance

  • Batch record review

  • GMP compliance

  • Batch Disposition

  • Batch Documentation

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • creativity

  • Attention to detail

  • Teamwork

  • Adaptability

  • Problem-Solving

  • Decision-making

Compensation

According to JobzMall, the average salary range for a Sr. Specialist, QA Batch Disposition in Kansas City, MO, USA is $80,000-$120,000 per year. This range may vary depending on the specific company, experience level, and other factors.

Additional Information
Catalent 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 PostedDecember 19th, 2023
Apply BeforeJuly 20th, 2025
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About Catalent

Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.

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