Quality Assurance Specialist (CDMO)

Main Role

The Quality Assurance Associate plays an important role in safeguarding product integrity and compliance across all pharmaceutical operations. This position is the bridge between manufacturing, regulatory requirements, and patient safety—reviewing, monitoring, and documenting processes to ensure they meet GxP, FDA, and global quality standards. The work of the Quality Assurance Associate directly influences the trust our patients place in our products, from raw material inspection to final product release.

Key Responsibilities

• Assist in the maintenance and tracking of all Quality related documentation including, but not limited to: SOPs, Protocols, Investigations, CAPAs, Planned Deviations, Change Controls, etc.
• Maintains all investigation and CAPA related documentation as assigned while ensuring adherence to, and compliance with, established company quality policies, practices, SOPs and cGMPs.
• Assists in investigations, root cause analysis, Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System.
• Tracks and trends appropriate metrics for open Investigations, CAPAs, planned deviations, etc.
• Reports monthly metrics pertaining to investigations and CAPAs to Quality department management and other appropriate company personnel.
• Actively participate in the review and approval of batch record documentation to support quality release of drug product in a timely manner.
• Perform risk assessment to determine safety and efficacy of products.
• Assist in change control management program and document archival.
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
• Perform routine audits of processes and establish gap analysis.
• Perform quality review of documentation and processes.
• Assists with SOP revision and participates in inspections, as needed.
• Assists in other areas of QA and may cross train across department, as neede

Required Studies

• Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or relevant field.

Required Experience & Skills

• Minimum of 3 years of experience in pharmaceutical manufacturing, quality assurance, and/or FDA regulated industry.
• Experience working with document management and training management systems preferred.
• Experience with small molecule API preferred.
• Previous experience in a CMO/CDMO environment preferred.
• Familiar with GxP, FDA, ICH, and OSHA requirements.
• Familiar with Microsoft Office applications (Word, Excel, etc.).
• Must be capable of wearing all protective wear as required. This includes, but not limited to, mask, gloves, gown, hairnet, safety goggles, etc.

Key Competencies

• Must have strong organizational skills and exceptional attention to detail.
• Proactive, self-driven, and solution-oriented mindset
• Strong collaboration and stakeholder management skills
• Excellent written and verbal communication skills, with the ability to translate complex compliance concepts for both technical and non-technical audiences
• Continuous improvement mindset with the ability to add value beyond basic compliance
• Excellent critical thinking and risk-based decision-making skills