Quality Assurance Associate

ESTEVE; Morton Grove (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

ESTEVE is seeking a Quality Assurance Associate to safeguard product integrity across pharmaceutical operations, bridging manufacturing, regulatory requirements, and patient safety by reviewing and documenting processes to meet GxP, FDA, and global quality standards.

Responsibilities include maintaining QA documentation, supporting investigations and CAPAs, reviewing batch records, performing risk assessments, and aiding in audits to ensure timely quality release of drug products.

Qualifications

• Bachelor’s degree in a biological science, chemistry, biomedical engineering, or related field.
• Minimum 3 years in pharmaceutical manufacturing, QA, or FDA-regulated industry.
• Experience with document management and training systems; API familiarity preferred.

Responsibilities

• Assist in maintenance and tracking of QA documentation (SOPs, protocols, investigations, CAPAs, deviations, change controls).
• Maintain investigation and CAPA documentation, ensuring compliance with quality policies and cGMPs.
• Assist in investigations, root cause analysis, and CAPA activities per Quality System.
• Track metrics for investigations and CAPAs; report monthly to QA management.
• Review batch records to support timely quality release of drug products.
• Perform risk assessments for product safety and efficacy.
• Support change control management and archival of documents.
• Maintain compliance with policies, regulatory requirements, and safety practices.
• Conduct routine process audits and gap analyses; review documentation quality.
• Assist in SOP revisions and participate in inspections as needed.

Skills

CAPA investigations

Quality systems

Documentation management

Risk assessment

Audits

Education

Bachelor’s Degree in Biological Science, Chemistry, Biomedical Engineering, or related field

Tools

MS Office

Job description

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.

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 needed

Requirements

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