Catalent

Senior Specialist, Client QA

Catalent

Harmans, Severn, MD, USA
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

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.

  1. Conduct thorough and timely quality reviews and audits of client's products and processes, ensuring compliance with relevant regulations and standards.
  2. Collaborate with cross-functional teams to identify and address any quality issues or concerns in a timely manner.
  3. Develop and implement quality assurance processes and procedures to ensure consistent and effective quality control.
  4. Train and mentor junior quality assurance team members to ensure a high level of quality and compliance across all operations.
  5. Serve as a subject matter expert on regulatory guidelines and requirements, providing guidance and support to internal teams and clients.
  6. Communicate and collaborate with clients to address any quality-related concerns and ensure their satisfaction.
  7. Analyze data and trends to identify potential areas for improvement and implement corrective actions as needed.
  8. Participate in internal and external audits and inspections, providing necessary documentation and support.
  9. Keep up-to-date on industry developments and changes in regulations, proactively incorporating them into quality assurance processes.
  10. Uphold Catalent's mission and values, consistently demonstrating a commitment to excellence and patient/consumer safety.
Where is this job?
This job is located at Harmans, Severn, MD, USA
Job Qualifications
  • 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.

Required Skills
  • Quality Assurance

  • Process Improvement

  • Data Analysis

  • Problem Solving

  • GMP Knowledge

  • Team Leadership

  • Risk assessment

  • Audit management

  • Regulatory compliance

  • Client management

  • Documentation management

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • collaboration

  • Adaptability

  • Problem-Solving

Compensation

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.

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 PostedMarch 13th, 2025
Apply BeforeJune 9th, 2026
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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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