
Senior Specialist, Client QA
At Catalent, our mission is to be the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, and consumer health products. We are looking for a highly skilled and experienced Senior Specialist to join our Client QA team. As a Senior Specialist, you will play a crucial role in ensuring the quality and compliance of our client's products and processes. Your expertise and attention to detail will be integral in maintaining our high standards and reputation in the industry. If you have a passion for quality assurance and a strong understanding of regulatory guidelines, we want to hear from you. Join us in making a difference in the lives of patients and consumers around the world.
- Conduct thorough and timely quality reviews and audits of client's products and processes, ensuring compliance with relevant regulations and standards.
- Collaborate with cross-functional teams to identify and address any quality issues or concerns in a timely manner.
- Develop and implement quality assurance processes and procedures to ensure consistent and effective quality control.
- Train and mentor junior quality assurance team members to ensure a high level of quality and compliance across all operations.
- Serve as a subject matter expert on regulatory guidelines and requirements, providing guidance and support to internal teams and clients.
- Communicate and collaborate with clients to address any quality-related concerns and ensure their satisfaction.
- Analyze data and trends to identify potential areas for improvement and implement corrective actions as needed.
- Participate in internal and external audits and inspections, providing necessary documentation and support.
- Keep up-to-date on industry developments and changes in regulations, proactively incorporating them into quality assurance processes.
- Uphold Catalent's mission and values, consistently demonstrating a commitment to excellence and patient/consumer safety.
Minimum Of 5 Years Of Experience In Quality Assurance Or Quality Control Within The Pharmaceutical Industry.
Bachelor's Degree In A Scientific Or Related Field, Such As Chemistry, Biology, Or Pharmacy.
In-Depth Knowledge Of Fda Regulations And Cgmp Guidelines.
Strong Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Clients.
Experience With Managing And Leading Client Audits And Inspections, As Well As Implementing Corrective And Preventive Actions.
Quality Assurance
Process Improvement
Data Analysis
Problem Solving
GMP Knowledge
Team Leadership
Risk assessment
Audit management
Regulatory compliance
Client management
Documentation management
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
collaboration
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Specialist, Client QA in Harmans, Severn, MD, USA is $75,000 - $90,000 per year. However, this may vary depending on factors such as the specific company, years of experience, and skills of the individual. Some companies may offer a higher salary for this role, while others may offer a lower salary. It is best to research the specific company and their salary ranges for this position to get a more accurate estimate.
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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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