Quality Assurance Associate

Responsibilities:

• Implement QA strategies and oversee GxP inspection preparedness, offering support as defined in 21 CFR Part 58, along with metrics collection and analysis.
• Conduct audits on raw data and comprehensive reports to ensure precision and adherence to GxP, study directives, and lab protocols.
• Assess laboratory Quality Assurance measures against established policies and best practices.
• Scrutinize all documents for compliance with the organization's quality benchmarks.
• Verify that the infrastructure, equipment, organizational hierarchy, processes, and protocols meet both regulatory and corporate criteria.
• Offer QA assistance for modification controls, deviations, inquiries, corrective and preventative actions (CAPAs), and follow-up evaluations.
• Generate and manage compliance-focused trend analyses and reporting.
• Propose recommendations for amendments and enhancements where needed.
• Supervise the management of personnel training records.
• Support the QA aspects of both internal and external audits as delegated.
• Regularly revise and enhance Quality Assurance methods.
• Preserve audit documentation and QA records.
• Undertake additional tasks as required.

Qualifications:

• A Bachelor's degree in Quality Assurance or a science-related discipline.
• A minimum of 5 years' experience in a GxP or equivalent regulatory setting.
• In-depth knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations.
• Practical knowledge of ISO 9001, ISO 17025, and ISO 17034 standards.
• Proficiency in evaluating laboratory data and computer-validated data collection systems within preclinical and clinical frameworks.
• Capability to audit established test methods against published standards to confirm their accuracy.
• Comprehensive understanding of regulatory mandates and relevant scientific literature for assured compliance.
• Expertise in conducting quality process audits, including the examination of deviations and CAPA processes.
• Proficient in Microsoft Office suite applications such as Excel, Word, and PowerPoint.
• Exceptional time and project management skills, with the ability to juggle multiple assignments under tight deadlines independently.
• Outstanding interpersonal skills to provide advice and collaborate with multidisciplinary teams.
• Excellent communication abilities, both oral and written, with a knack for understanding and verifying scientific text and data.

Preferred Qualifications:

• An educational background or professional experience in molecular biology, virology, and/or serology.
• Previous engagement with a Contract Research Organization (CRO).
• Familiarity with electronic Quality Management Systems (eQMS), preferably Qualio.