Catalent

Quality Assurance Specialist, Commercial Manufacturing

Catalent

Greenville, NC, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Catalent, a leading pharmaceutical manufacturing company committed to improving the lives of patients worldwide. We are seeking a highly motivated Quality Assurance Specialist to join our Commercial Manufacturing team. This role requires a detail-oriented and analytical individual with a passion for ensuring the highest level of quality in our products. If you have a strong background in quality assurance and are looking for an opportunity to make a meaningful impact in the pharmaceutical industry, we encourage you to apply.

  1. Conduct thorough quality inspections of all products and processes to ensure compliance with company standards and regulatory requirements.
  2. Create and maintain detailed quality control procedures and protocols for all stages of production.
  3. Collaborate with cross-functional teams to identify and resolve any quality-related issues or concerns.
  4. Conduct internal and external audits to assess and improve quality management systems.
  5. Monitor and analyze data to identify trends and areas for improvement in product quality.
  6. Communicate and report quality metrics and findings to management and relevant stakeholders.
  7. Develop and implement corrective and preventive action plans to address quality issues and prevent their recurrence.
  8. Stay up-to-date on industry regulations and standards to ensure compliance in all quality assurance processes.
  9. Train and mentor other team members on quality assurance protocols and procedures.
  10. Act as a liaison between the company and regulatory bodies during inspections and audits.
  11. Continuously assess and improve quality control processes to optimize efficiency and effectiveness.
  12. Contribute to the development and improvement of product specifications and quality standards.
  13. Identify and implement new technologies and methods to enhance quality assurance processes.
  14. Uphold the company's commitment to patient safety and product efficacy through diligent quality assurance practices.
  15. Foster a culture of quality consciousness and continuous improvement within the organization.
Where is this job?
This job is located at Greenville, NC, USA
Job Qualifications
  • Minimum Of 2-3 Years Of Experience In A Quality Assurance Role Within The Pharmaceutical Or Biotech Industry.

  • Bachelor's Degree In A Relevant Scientific Field, Such As Biology, Chemistry, Or Pharmaceutical Sciences.

  • Strong Understanding Of Cgmp Regulations And Guidelines, As Well As Fda And Other Regulatory Agency Requirements.

  • Experience With Quality Systems, Such As Document Control, Change Control, And Deviation Management.

  • Excellent Communication And Problem-Solving Skills, With The Ability To Work Cross-Functionally With Various Departments And Teams.

Required Skills
  • statistical analysis

  • Quality Control

  • Root Cause Analysis

  • Process validation

  • Risk assessment

  • GMP compliance

  • Document Review

  • SOP Development

  • Audit Preparation

  • Batch Release

  • Capa Management

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Quality Assurance Specialist, Commercial Manufacturing in Greenville, NC, USA is $50,000 - $80,000 per year.

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 BeforeApril 11th, 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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