Quality Assurance Associate

Job Description

Job Title:

Quality Assurance Associate

The Quality Assurance Associate plays a vital role in protecting product integrity and ensuring compliance across all pharmaceutical operations. This position serves as a key link between manufacturing, regulatory requirements, and patient safety by reviewing, monitoring, and documenting processes to ensure alignment with GxP, FDA, and global quality standards. From raw material inspection through final product release, the Quality Assurance Associate helps safeguard the quality of products and reinforces the trust that patients place in them.

• Assist in the maintenance, tracking, and organization of all quality-related documentation, including SOPs, protocols, investigations, CAPAs, planned deviations, change controls, and related records.
• Maintain investigation and CAPA documentation as assigned while ensuring adherence to company quality policies, SOPs, cGMPs, and established practices.
• Support and participate in investigations, root cause analysis, and Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System.
• Track and trend key metrics for open investigations, CAPAs, planned deviations, and other quality events to support continuous improvement.
• Prepare and report monthly metrics related to investigations and CAPAs to Quality department leadership and other relevant stakeholders.
• Actively participate in the review and approval of batch record documentation to support timely quality release of drug product.
• Perform risk assessments to evaluate the safety and efficacy of products and recommend appropriate actions based on findings.
• Assist in the change control management program, including documentation, tracking, and archival of change control records.
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
• Conduct routine audits of processes, identify gaps through structured gap analysis, and support remediation activities.
• Perform quality reviews of documentation and processes to ensure accuracy, completeness, and regulatory compliance.
• Assist with SOP revisions and updates, ensuring that procedures reflect current practices and regulatory expectations.
• Participate in internal and external inspections and audits as needed, providing documentation and support to inspectors and auditors.
• Collaborate with QA colleagues and cross-functional teams, and cross-train in other areas of Quality Assurance as needed to support departmental needs.
• Engage professionally with external parties including quality consultants, quality auditors, regulatory authorities, clients, and customers as part of quality-related activities.

• Minimum of 3 years of experience in pharmaceutical manufacturing, quality assurance, and/or other FDA-regulated industry.
• Bachelor’s degree in Biological Science, Chemistry, Biomedical Engineering, or a closely related field.
• Hands‑on experience with investigations, root cause failure analysis, deviations, CAPA activities, and audit support in a regulated environment.
• Experience with batch record review and product release processes within pharmaceutical or related operations.
• Familiarity with GxP, FDA, ICH, and OSHA requirements and the ability to apply these guidelines in daily work.
• Understanding of laboratory, QC, and QA environments and their roles in supporting product quality.
• Proficiency with Microsoft Office applications, including Word and Excel.
• Strong organizational skills and exceptional attention to detail in documentation and record‑keeping.
• Proactive, self‑driven, and solution‑oriented approach to managing quality issues and process improvements.
• Strong collaboration and stakeholder management skills, with the ability to work effectively across QA, QC, production, and external partners.
• Excellent written and verbal communication skills, including the ability to explain complex compliance concepts to both technical and non‑technical audiences.
• Demonstrated critical thinking and risk‑based decision‑making skills in assessing product quality and compliance.
• Ability to wear required…