QA Specialist

The QA Specialist will be responsible for ensuring compliance with all quality assurance and regulatory requirements at the Xseer Pharmaceuticals 503B compounding facility. This role involves the development, implementation, and monitoring of quality systems to guarantee the safety, efficacy, and quality of compounded medications. Key Responsibilities: Quality Assurance Oversight: - Monitor and evaluate processes to ensure compliance with FDA regulations, USP guidelines, and internal quality standards. - Conduct regular audits and inspections of the compounding facility and processes. Documentation and Record Keeping: - Maintain accurate records of all quality assurance activities, including batch records, deviation reports, and corrective action plans. - Review and approve batch records for accuracy and completeness, ensuring that all processes are properly documented and in compliance with regulations. Document Control: - Manage the document control system to ensure that all quality documents, including SOPs, training records, and validation documents, are current and properly archived. - Implement and oversee the document review and approval process, ensuring timely updates and revisions as needed. Investigations and CAPA: - Assist in the Investigation of product quality issues, non-conformances, and customer complaints. - Implement corrective and preventive actions (CAPA) to address quality issues and improve processes. - Work closely with compounding pharmacists, operations, and other departments to foster a culture of quality. - Participate in cross-functional teams to improve processes and systems. Qualifications: - Bachelor’s degree in pharmacy, chemistry, biology, or a related field. - Minimum of 2 years of experience in quality assurance, preferably in a pharmaceutical or compounding environment. - Knowledge of FDA regulations, USP standards, and cGMP guidelines. - Strong analytical and organizational skills and attention to detail. - Excellent communication and interpersonal skills. - Ability to work independently and as part of a team. Preferred Qualifications: - Certification in quality assurance or a related field (e.g., ASQ, CQIA). - Experience in a 503B compounding facility.

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