Quality Compliance & Documentation Specialist

Integrated Resources, Inc ( IRI ); New Haven (CT); On-site; USD 70,000 - 100,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) is seeking an ADQC Compliance Specialist to provide comprehensive compliance and documentation support to the ADQC and Clinical QC laboratories. This role focuses on maintaining ALCOA+ standards, ensuring data integrity, and adhering to cGMP procedures.

The candidate will assist with change controls, deviations, investigations, and periodic reviews, while supporting the equipment qualification program and EQV system to ensure regulatory compliance across

Qualifications

• Minimum BS/BA in a relevant field with 2–5 years in cGMP settings.
• Knowledge of Pharmaceutical Quality Assurance and regulatory compliance.
• Strong documentation and data management skills.

Responsibilities

• Provide compliance and documentation support to the ADQC/clinical QC labs.
• Ensure ALCOA+ data integrity and adherence to cGMP procedures.
• Support change controls, deviations, investigations, and CAPAs.
• Coordinate periodic reviews, equipment qualification, and EQV system tasks.
• Assist with audits and review new procedures for regulatory compliance.

Skills

cGMP knowledge

Quality Assurance

Regulatory compliance

Documentation management

Data analysis

Education

BS/BA in related field

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

Job description

Integrated Resources, Inc ( IRI ) is seeking an ADQC Compliance Specialist to provide comprehensive compliance and documentation support to the ADQC and Clinical QC laboratories. This role focuses on maintaining ALCOA+ standards, ensuring data integrity, and adhering to cGMP procedures.

The candidate will assist with change controls, deviations, investigations, and periodic reviews, while supporting the equipment qualification program and EQV system to ensure regulatory compliance across