
Quality Assurance Specialist, Commercial Manufacturing
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.
- Conduct thorough quality inspections of all products and processes to ensure compliance with company standards and regulatory requirements.
- Create and maintain detailed quality control procedures and protocols for all stages of production.
- Collaborate with cross-functional teams to identify and resolve any quality-related issues or concerns.
- Conduct internal and external audits to assess and improve quality management systems.
- Monitor and analyze data to identify trends and areas for improvement in product quality.
- Communicate and report quality metrics and findings to management and relevant stakeholders.
- Develop and implement corrective and preventive action plans to address quality issues and prevent their recurrence.
- Stay up-to-date on industry regulations and standards to ensure compliance in all quality assurance processes.
- Train and mentor other team members on quality assurance protocols and procedures.
- Act as a liaison between the company and regulatory bodies during inspections and audits.
- Continuously assess and improve quality control processes to optimize efficiency and effectiveness.
- Contribute to the development and improvement of product specifications and quality standards.
- Identify and implement new technologies and methods to enhance quality assurance processes.
- Uphold the company's commitment to patient safety and product efficacy through diligent quality assurance practices.
- Foster a culture of quality consciousness and continuous improvement within the organization.
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.
statistical analysis
Quality Control
Root Cause Analysis
Process validation
Risk assessment
GMP compliance
Document Review
SOP Development
Audit Preparation
Batch Release
Capa Management
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
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.
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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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