Quality Control Analyst

Job Description

Position Overview:

Aegis Worldwide is seeking a Quality Control Testing Engineer to join a dynamic and regulated pharmaceutical manufacturing environment. This role supports the Quality Control (QC) department by leading investigations, managing change controls, driving continuous improvement initiatives, and ensuring strict compliance with current Good Manufacturing Practices (cGMP) and global regulatory standards.

Key Responsibilities:

Lead or support investigations for Out-of-Specification (OOS) results and procedural deviations.

Implement effective Corrective and Preventive Actions (CAPAs) to ensure root cause resolution.

Maintain compliance with U.S. and international regulations (FDA, EU, USP, ISO, cGMP, NRC, TGA, etc.).

Prepare or review Change Controls for SOPs, test methods, and data sheets.

Utilize quality tools such as FMEA, 5 Whys, Fishbone Diagrams, and Risk Analysis for investigations and process improvements.

Conduct statistical analysis on laboratory data to support investigations and cost-saving initiatives.

Author and execute method validation and equipment qualification protocols.

Work with radioactive materials in a safe and compliant manner.

Support internal and external audits, including those by regulatory bodies (e.g., FDA).

Maintain current knowledge of Microbiology, Chemistry, and pharmaceutical industry standards.

Foster a culture of safety, quality, and compliance through training and leadership.

Qualifications:

Bachelor’s degree in Biology, Chemistry, or a related scientific field required.

Minimum of 5 years of experience in a pharmaceutical or regulated manufacturing environment.

Prior experience with OOS investigations and exception management preferred.

Strong analytical, investigative, and decision-making skills under pressure.

Demonstrated knowledge of Root Cause Analysis and problem-solving methodologies.

Proficient in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).

Strong written and verbal communication skills.

Ability to manage multiple projects and priorities independently.

Excellent attention to detail and commitment to quality standards.

Experience working in a cGMP-compliant laboratory or manufacturing environment required.

Full-time