Quality Assurance Specialist — cGMP & Documentation

Sharp Clinical Services, Inc.; Town of Bethlehem (NY); Hybrid; USD 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

On-site 3 days/week

Job summary

Sharp Clinical Services, Inc. in New York State is seeking a Quality Assurance Specialist to ensure product and process quality, and cGMP compliance across departments. The role emphasizes right-first-time documentation and timely quality issue communication.

The ideal candidate will review batch records, QC reports, labels, COAs and distribution instructions, while contributing to CAPA, change control, and training to maintain Sharp’s high standards.

Qualifications

• Bachelor's/Associate degree in science or technical field preferred.
• 3 years relevant work experience in a cGMP environment.
• Ability to interpret and implement cGMPs, FDA & DEA regulations.
• Excellent written and verbal communication skills.

Responsibilities

• Review and approve batch records for cGMP compliance.
• Review and approve QC reports to ensure quality standards are met.
• Review and approve labels, COAs, and distribution instructions.
• Prepare APR reports in compliance with FDA and EU regulations.
• Investigate non-conformances and support CAPA and change control.

Skills

cGMP knowledge

Documentation control

Problem solving

Cross-functional collaboration

Microsoft Office

Education

Bachelor's or Associate degree in science/technical field

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft Access

Job description

Sharp Clinical Services, Inc. in New York State is seeking a Quality Assurance Specialist to ensure product and process quality, and cGMP compliance across departments. The role emphasizes right-first-time documentation and timely quality issue communication.

The ideal candidate will review batch records, QC reports, labels, COAs and distribution instructions, while contributing to CAPA, change control, and training to maintain Sharp’s high standards.