
Quality Assurance Specialist
7 days ago
Overview:
">Quality Assurance Specialist - API External Manufacturing">We are seeking a skilled Quality Assurance Specialist to join our team in ensuring the quality of our API external manufacturing processes.
">Main Responsibilities:
">- ">
- Provide quality oversight of Contract Manufacturing Organizations (CMs) and ensure compliance with cGMPs and regulatory commitments.">
- Serve as a liaison between CMs and our organization, providing initial point of contact for all quality-related issues.">
- Evaluate and disposition API batches, ensuring that documented checks have been completed for Certificates of Testing and Certificates of Environmental Monitoring.">
- Assess the impact of deviation investigations and changes, ensuring that all appropriate records are documented and retrievable.">
- Maintain awareness of external regulatory agency findings and review/approve documents related to quality control activities.">
Requirements:
">Bachelor's Degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences is required.
">Five plus years of GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QA is required.
">Demonstrated coaching and mentoring skills, thorough technical understanding of quality systems and regulatory requirements, and excellent interpersonal skills are preferred.
">We offer a dynamic work environment, competitive compensation package, and opportunities for professional growth and development.
">At our organization, we are committed to helping individuals with disabilities to actively engage in the workforce and ensure equal opportunities when vying for positions.
">If you require accommodation to submit a resume for a position at our organization, please complete the accommodation request form for further assistance.
">We do not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
">We value diversity and inclusion in the workplace and welcome applications from qualified candidates from diverse backgrounds.
">Please note that this email address is intended for use only to request an accommodation as part of the application process.
">Languages: English
">Job Type: Full-time
">Language: en
"] ,-
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