Lead Specialist, QA Batch Disposition

We are seeking a highly motivated Lead Specialist, Quality Assurance Batch Disposition to join our team at Catalent. In this role, you will be responsible for providing leadership in the implementation and maintenance of Quality Assurance batch record disposition activities. You will be a key member of the Quality Assurance team, providing guidance and expertise in the areas of batch record review and disposition, as well as compliance with cGMP requirements.To be successful in this role, you must have a Bachelors Degree in Science or a related field and a minimum of 3 years of experience in a Quality Assurance Batch Disposition role. You must also have an in-depth knowledge of cGMP regulations and FDA requirements for the manufacture of pharmaceuticals. Additionally, you should have strong communication and problem-solving skills, and be able to work independently or as part of a team.If you are looking for an opportunity to use your technical expertise to make a real impact in the pharmaceutical industry, this is the role for you. We are looking for a leader with a passion for quality and a commitment to excellence.

Responsibilities:

1. Lead and manage the implementation and maintenance of Quality Assurance batch record disposition activities.
2. Ensure compliance with cGMP requirements and FDA regulations for the manufacture of pharmaceuticals.
3. Develop and maintain Quality Assurance SOPs, policies, and guidance documents.
4. Ensure batch record review and disposition is conducted accurately and in a timely manner.
5. Collaborate with other departments to ensure the efficient and compliant release of products to customers.
6. Perform regular audits to ensure compliance with cGMP and other regulatory requirements.
7. Monitor and review quality performance metrics and take corrective action when necessary.
8. Provide technical guidance and support to other team members.
9. Troubleshoot issues with batch records and other Quality Assurance activities.
10. Maintain a regular presence on the production floor to ensure compliance and adherence to cGMP requirements.

According to JobzMall, the average salary range for a Lead Specialist, QA Batch Disposition in Baltimore, MD, USA is from $46,000 to $67,000. This salary range may vary depending on the size of the company, the industry, and the location.

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.