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Katalyst CRO

Quality Assurance (QA) Specialist

Katalyst CRO, Boston, Massachusetts, us, 02298

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Quality Assurance (QA) Specialist

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Quality Assurance (QA) Specialist

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Katalyst CRO Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.

Responsibilities

Monitor compliance with GMP, FDA, and regulatory requirements throughout manufacturing. Conduct inspections, audits, and testing to ensure products meet quality standards. Review batch records, documentation, and processes for compliance with quality protocols. Investigate deviations, non-conformances, and customer complaints, implementing corrective actions. Assist with the preparation for regulatory audits and inspections. Support the development and maintenance of quality assurance systems and procedures. Collaborate with cross-functional teams to resolve quality issues and improve processes. Review and update Standard Operating Procedures (SOPs), batch records, and documentation. Train staff on GMP guidelines and company quality policies.

Requirements:

Bachelor's degree in Pharmaceutical Sciences, Life Sciences, Chemistry, or a related field. 2+ years of experience in Quality Assurance, preferably in the pharmaceutical or biotechnology industry. Strong understanding of GMP, FDA regulations, and industry standards. Experience with pharmaceutical manufacturing processes and quality control testing. Strong attention to detail and communication skills. Proficiency with Microsoft Office Suite; experience with quality management software is a plus. Seniority level

Seniority level Associate Employment type

Employment type Contract Job function

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