
Specialist, QA Batch Disposition
We are looking for an experienced and detail-oriented Specialist, QA Batch Disposition to join our team at Catalent. In this role, you will be responsible for ensuring the quality of drug products that enter the marketplace by reviewing batch records, dispositioning of products, and providing technical guidance to manufacturing. The ideal candidate should have a strong understanding of cGMP and FDA regulations, as well as excellent technical and problem-solving skills. We are looking for a team player who has a desire to help improve our processes and drives for continuous improvement. If you are up for the challenge and possess the qualifications listed below, we would love to hear from you!
Responsibilities:
- Ensure that drug products meet cGMP and FDA regulations prior to entering the marketplace.
- Review batch records and disposition products according to established standards.
- Provide technical guidance to manufacturing to ensure quality of products.
- Develop and implement quality control procedures to improve processes.
- Maintain accurate records of product testing and batch dispositioning.
- Monitor trends in quality assurance and take corrective action when needed.
- Work with cross-functional teams to develop and maintain product specifications.
- Investigate customer complaints and provide corrective action where needed.
- Monitor and audit quality control systems for compliance with cGMP and FDA regulations.
- Perform routine analytical testing as needed to ensure quality of products.
• Bachelor’s Degree In Science Or Related Field
• + Years Of Relevant Experience In A Regulated Environment
• Knowledge Of Cgmp And Fda Regulations
• Ability To Analyze And Interpret Data And Identify Trends
• Ability To Write And Review Batch Documents
• Excellent Written And Verbal Communication Skills
• Proficiency In Microsoft Office Suite
• Strong Organizational And Time Management Skills
Testing
Troubleshooting
Auditing
Reporting
Documenting
Monitoring
Sampling
Analyzing
Inspecting
Calibrating
Verifying
Updating
Investigating
Validating
Communication
Decision Making
Leadership
Time management
Interpersonal Skills
Critical thinking
Organizational skills
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Specialist, QA Batch Disposition in Baltimore, MD, USA is $50,000 to $70,000. This range may vary depending on the experience level of the specialist and the company offering the job.
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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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