Quality Assurance Lead

Job Description

Ultimate Staffing is currently assisting our client in the Atlanta, GA area with a Quality Assurance Lead opportunity. The Quality Assurance Lead supports the execution and continuous improvement of the quality management system across manufacturing operations, suppliers, and regulatory compliance activities. This role focuses on ensuring adherence to FDA/EPA regulations, GMP standards, and internal quality requirements through daily oversight, audit support, and cross-functional collaboration. The position plays a key role in maintaining inspection readiness, driving compliance activities, and supporting audit and quality governance processes.

• Direct Hire opportunity in Atlanta, GA (Airport area)
• Salary BOE $80K-$90K with 8% annual bonus incentive
• Full benefits offered- medical, dental, vision, 401K with match etc.

Key Responsibilities:

* Support the execution of risk-based audit programs across internal sites, suppliers, and external partners, ensuring alignment with FDA, EPA, and GMP requirements.

* Leading and maintaining audit standards, scoring methodologies, and reporting practices to ensure consistency and regulatory compliance.

* Participate in internal and external audits, including preparation, coordination, and follow-up of corrective actions.

* Conduct routine compliance reviews of QC activities and batch records to ensure adherence to Good Documentation Practices (GDP), GMP, EPA, and FDA regulations.

* Review and support approval of batch records, ensuring completeness and accuracy prior to product release.

* Monitor and track audit findings, deviations, and CAPAs to ensure timely closure and compliance with regulatory expectations.

* Lead investigation of deviations, customer complaints, and quality events, including root cause analysis and documentation.

* Contribute to CAPA activities, including tracking, documentation, and verification of effectiveness.

* Lead the preparation and review of Annual Product Reports (APRs) and other regulatory documentation.

* Help maintain inspection readiness by performing routine compliance checks and supporting FDA and other regulatory inspections.

* Review and maintain Standard Operating Procedures (SOPs) to ensure alignment with current regulatory and operational requirements.

* Maintain quality documentation and ensure proper document control, versioning, and accessibility within the QMS/eQMS.

* Support monitoring of equipment maintenance records to ensure compliance with GMP requirements.

* Assist in delivering GMP training and reinforcing a culture of quality and compliance.

* Coordinate quality notifications and support timely communication and resolution with customers and internal stakeholders.

* Support creation and review of intermediate and finished product labeling to ensure compliance with regulatory standards.

* Analyze recurring quality issues and audit findings to support continuous improvement initiatives.

* Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Operations teams to support compliance and quality objectives.

* Coach and lead junior QA associates.

Qualifications:

* 5+ years of experience in Quality Assurance, manufacturing quality, or compliance in an FDA-regulated environment.

* Working knowledge of FDA regulations, GMP, ISO, and quality system requirements.

* Experience supporting audits, inspections, and quality systems processes (CAPA, deviations, complaints).

* Strong attention to detail with the ability to review and interpret technical documentation and data.

* Demonstrated ability to coordinate across teams and support cross-functional initiatives.

* Effective written and verbal communication skills.

* Experience with eQMS systems (e.g., Intelex or similar) preferred.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.


Job Reference: JN -062026-423766