Quality 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

• ADQC Compliance Specialist is responsible for performing assigned administrative tasks while maintaining the highest standard of quality and compliance in ADQC and the Clinical QC (GMP) laboratories.
• This candidate will be responsible for administrative duties such as data archival, ALCOA+ documentation management, assurance/adherence to local GMP procedures, initiation and support of change controls, deviations and investigations (as applicable) relevant to ADQC biologic and gene therapy programs.
• Additionally, this candidate will be assisting the CQC Compliance team with the Clinical QC periodic review process, equipment qualification program and EQV system, ensuring quality requirements are met per procedure and performing relevant assigned compliance tasks as assigned.

You will be responsible for:

• This is not a laboratory-based position. The specialist will provide compliance and documentation support to the laboratory.
• Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records.
• Responsible for generating, reviewing, and providing assessments for Quality records for Analytical Development and Quality Control (ADQC) ensuring compliance with regulatory standards, maintaining of data integrity, and optimizing system performance.
• Track and present schedules internally for compliance related events in ADQC (Periodic reviews, system qualification and validation activities, guidance document updates, system obsolescence and upgrade needs etc.)
• Compliance involvement for laboratory investigation reports, deviation reports, CAPAs.
• Provide backroom assistance for Quality audits.
• Conduct reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements.
• Assist compliance team with equipment maintenance and management as needed.
• Strong verbal communication and presentation skills.
• Create plans and present timelines to meet established targets, goals and objectives.

You will need to have:

• A successful candidate will have a minimum of BS/BA degree in a relevant field with 2-5 years of experience working in cGMP setting.
• Knowledge of Pharmaceutical Quality Assurance, regulatory compliance and/or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Strong working knowledge of Microsoft suite programs.
• Effectively organize and manage work responsibilities. Excellent time and project management skills with the ability to multi-task.
• Strong proficiency in quality management systems and audit procedures.
• Strong and effective communication skills for interacting with cross-functional teams.
• Mental Acuity: High attention to detail and ability to maintain accuracy in documentation and processes. Strong analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
• Physical Requirements: Ability to bend, reach and stand, with lifting up to 15 pounds and carry over short distances.

We would prefer you to have:

• Working knowledge in validated documentation systems: Veeva Vault (EQV), LIMS, ValGenesis, Kneat, etc.
• Knowledge of pharmaceutical/biotechnology manufacturing process.