Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Job Description

• The Quality Assurance team within the Worldwide Operations Manufacturing department is seeking an enthusiastic, results-oriented, and experienced Quality Assurance Specialist to join our organization as a Remote Worker.
• The candidate will be responsible for supporting the global Manufacturing Execution System (MES) projects and initiatives to ensure compliance, quality assurance, and operational excellence in a GMP-regulated environment.
• This is an excellent opportunity for a highly experienced and talented individual to contribute to mission of serving patients.

Responsibilities:

• Ensure quality oversight and compliance for MES and PT project activities.
• Support validation and qualification efforts for computerized systems in alignment with GMP requirements.
• Review and approve documentation related to MES workflows, change controls, and deviations.
• Collaborate with cross-functional teams to ensure quality standards are met during system implementation.
• Participate in risk assessments and support mitigation strategies for quality-related issues.
• Ensure that quality processes and procedures are updated and aligned with project deliverables.
• Provide training and guidance on quality practices and regulatory compliance.
• Support audits and inspections by providing documentation and subject matter expertise.
• Monitor and report on quality metrics and continuous improvement initiatives.
• Ensure alignment with global quality standards and local regulatory requirements.

Requirements :

• Bachelor's or master's degree in Life Sciences, Engineering, or related field.
• Proven experience in quality assurance within a GMP-regulated manufacturing environment.
• Experience supporting MES and process transformation initiatives.
• Strong understanding of validation principles and regulatory compliance.
• Excellent documentation and communication skills.
• Ability to work collaboratively in cross-functional teams.
• Detail-oriented with strong analytical and problem-solving skills.
• At least 5 years of experience in quality assurance or related roles.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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