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Quality Assurance Specialist
2 months ago
Job Title: Quality Assurance Specialist
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.
Key Responsibilities:
- Provide direct manufacturing Quality Assurance support for all Good Manufacturing Practice (GMP) activities.
- Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support.
- Ensure compliance with cGMP regulations and applicable standards.
- Work independently to resolve Quality Assurance issues and develop solutions for complex problems in line with cGMP regulations.
- Maintain a state of inspection readiness by reviewing batch records and interacting with interdepartmental contacts on discrepancy assessment and resolution.
- Support process improvement initiatives and advocate for diversity, equity, and inclusion.
Requirements:
- Strong knowledge of Quality Assurance principles and cGMP regulations.
- Excellent problem-solving and analytical skills.
- Ability to work independently and collaboratively as part of a team.
- Strong communication and interpersonal skills.
- Ability to maintain confidentiality and handle sensitive information.
Preferred Qualifications:
- Experience in a manufacturing or pharmaceutical industry setting.
- Knowledge of quality management systems and regulatory requirements.
- Certifications such as CQA or CQE.