Quality Assurance Specialist

Quality Assurance Specialist

Job Description:

We are seeking a dedicated Quality Assurance Specialist to join our team in Siloam Springs, AR. In this pivotal role, you will be responsible for reviewing and updating standard operating procedures (SOPs) to ensure they are accurate and comply with industry standards and regulations. Your expertise will be crucial in conducting thorough reviews of batch records and manufacturing processes, ensuring compliance with both regulatory requirements and internal quality standards. You will collaborate closely with our Computer System Validation (CSV) team to assess their work and ensure that our software systems meet the necessary quality assurance benchmarks. Additionally, you will provide essential support during audits by preparing documentation and insights that facilitate our compliance efforts. Your responsibilities will also include conducting quality reviews to pinpoint areas for improvement, thereby ensuring that our processes adhere to the highest quality standards. Excellent written and verbal communication skills are essential, as you will be tasked with producing clear and comprehensive reports and documentation that reflect our commitment to quality.

IT Languages:

• Python
• SQL
• Java

As a Quality Assurance Specialist, you will engage in a variety of critical responsibilities that ensure our products meet the highest standards of quality and compliance.:

Evaluate and update standard operating procedures to maintain accuracy and compliance.;; Conduct comprehensive reviews of batch records and manufacturing processes.;; Collaborate with the CSV team to ensure software systems comply with quality assurance standards.;; Assist in audit processes by providing necessary documentation and insights.;; Perform quality reviews of documentation and processes to identify and implement improvements.

Spoken Languages:

• English;; Spanish

Skillset:

• Quality management
• Regulatory compliance
• Batch record review
• Documentation skills

Soft Skills:

• Attention to detail
• Analytical thinking
• Team collaboration
• Effective communication

Qualifications:

• Bachelor's degree in Life Sciences, Quality Assurance, or a related field preferred.
• Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• Strong knowledge of FDA regulations, cGMP, and quality management systems.

Years of Experience:

5

Location:

Siloam Springs, AR, United States

Job Benefits:

• Health insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Working Conditions:

Full Time

Employment Type:

Permanent Contract

Company Culture:

• We foster a collaborative and innovative environment where quality is paramount. Our team is dedicated to continuous improvement and professional development, ensuring that every member is empowered to contribute to our collective success.

Opportunities For Advancement:

• Leadership roles in quality assurance, Specialization in regulatory affairs, Cross-departmental projects

Visa Sponsorship:

Available