Job Title: Quality Specialist

Work Location: Franklin County, NY

Summary:

Seeking a detail-oriented Quality Specialist to support sterility and endotoxin testing in a cGMP-compliant environment. This role ensures regulatory compliance, supports continuous improvement, and facilitates the adoption of new testing methodologies within a microbiological quality control setting.

Responsibilities:

• Review and approve Quality Control documentation, including test data, logbooks, equipment qualification records, and reports for sterility and endotoxin testing services.
• Perform timely batch record reviews and support the release of finished sterile products by evaluating associated quality event documents.
• Participate in internal, external, and regulatory audits as a subject matter expert, ensuring compliance with cGMP, USP, EP, and other regulatory standards.
• Lead or support investigations of deviations, OOS results, and complaints, including root cause analysis and development of CAPAs.
• Develop, revise, and approve SOPs and controlled documents impacting sterility assurance and laboratory practices.
• Analyze environmental and utility monitoring data to identify trends and ensure effective contamination control strategies.
• Support validation activities for sterilization processes, test methods, and equipment, including review and approval of protocols and reports.
• Provide training and guidance to staff on quality standards, aseptic techniques, and regulatory requirements, while supporting process improvements and troubleshooting issues.

Qualifications:

• Bachelor’s degree in microbiology, biology, biotechnology, chemistry, or related scientific field (or equivalent experience/combination of education and experience).
• Minimum 3 years’ experience in a cGMP-regulated environment, preferably in microbiological testing or quality roles.
• Regulatory knowledge for sterility and endotoxin testing (e.g., LAL assays, membrane filtration) required.
• Experience supporting method development or validation for new testing services strongly preferred.
• Familiarity with aseptic processing and cleanroom environments preferred.
• Strong understanding of USP 71 and other relevant regulatory guidelines (FDA, EMA, ICH).
• Ability to manage multiple tasks and projects under deadline pressure and adapt quickly to change.
• Excellent documentation, organizational, verbal, and written communication skills; proficiency with Microsoft Office Suite and Quality systems (e.g., LIMS, QMS).
• Highly analytical, detail-oriented, and able to work cross-functionally in a fast-paced, regulated setting.
• Team player with strong critical thinking and problem-solving skills.

Published Category: Quality & Validation