QA/QC Analyst I

Job Title: QA/QC Analyst

Company: AstraZeneca

Overview: The QA/QC Analyst at AstraZeneca is likely responsible for ensuring the quality and compliance of products and processes within the company's pharmaceutical manufacturing or research facilities. This role involves various activities related to quality assurance, quality control, and compliance with regulatory standards to ensure the safety, efficacy, and integrity of pharmaceutical products.

Key Responsibilities:

1. Quality Assurance: Implement and maintain quality assurance systems and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA). Participate in internal and external audits to assess compliance and identify areas for improvement.

2. Quality Control: Perform routine testing and analysis of raw materials, in-process samples, and finished products to ensure compliance with quality standards and specifications. Utilize analytical techniques and instrumentation to assess product quality and identify deviations or non-conformances.

3. Documentation: Maintain accurate and comprehensive documentation of quality control activities, test results, and deviations. Ensure that documentation meets regulatory requirements and follows Good Documentation Practices (GDP).

4. Investigation and Problem-Solving: Investigate deviations, out-of-specification results, and quality issues to determine root causes and implement corrective and preventive actions (CAPAs) to address underlying issues and prevent recurrence.

5. Validation and Qualification: Participate in validation and qualification activities for equipment, processes, and analytical methods. Ensure that validation protocols and reports are executed and documented according to regulatory requirements and company standards.

6. Change Control: Assess and approve changes to processes, procedures, equipment, and materials to ensure that they do not adversely affect product quality, safety, or efficacy. Review change control documentation and provide recommendations as needed.

7. Training and Compliance: Provide training on quality assurance and quality control procedures, standards, and best practices to employees involved in manufacturing, testing, and quality assurance activities. Ensure that personnel are adequately trained and compliant with relevant regulations and standards.

8. Continuous Improvement: Identify opportunities for process improvement, efficiency gains, and cost savings within the quality assurance and quality control functions. Implement continuous improvement initiatives to enhance product quality, compliance, and operational effectiveness.

Qualifications:

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or a related field. Advanced degree or relevant certifications (e.g., ASQ certification) may be preferred.
• Previous experience in quality assurance, quality control, or analytical testing within the pharmaceutical or biotechnology industry.
• Strong knowledge of regulatory requirements and guidelines (e.g., cGMP, GLP, ICH) governing pharmaceutical manufacturing and testing.
• Experience with analytical techniques and instrumentation commonly used in pharmaceutical quality control (e.g., HPLC, GC, FTIR, UV-Vis).
• Excellent attention to detail, organizational skills, and problem-solving abilities.
• Effective communication and interpersonal skills with the ability to collaborate across different functions and levels within the organization.
• Ability to work independently and as part of a team in a fast-paced and regulated environment.