Quality Assurance (QA) Specialist - Katalyst CRO : Job Details

Join to apply for the Quality Assurance (QA) Specialist role at Katalyst CRO

Join to apply for the Quality Assurance (QA) Specialist role at 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 levelAssociate

Employment type

• Employment typeContract

Job function

• Job functionQuality Assurance
• IndustriesPharmaceutical Manufacturing

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