What are the responsibilities and job description for the Quality Assurance Compliance Specialist position at Intellectt Inc?
Role: Quality Compliance Specialist (EIDA Systems)
Location: Richmond, VA (Onsite)
Duration: 12 Months (Possible to extend)
Position Overview: Our client, a leading pharmaceutical manufacturing organization, is seeking an experienced Quality Compliance Specialist to support critical quality and compliance initiatives associated with EIDA systems and site projects. This role will be responsible for ensuring documentation integrity, regulatory compliance, validation readiness, and quality oversight throughout the project lifecycle. The ideal candidate will possess strong expertise in FDA-regulated pharmaceutical environments, quality systems, EIDA documentation, validation practices, and compliance management.
Key Responsibilities
- Serve as the Quality Compliance lead for EIDA-related systems, ensuring adherence to FDA regulations, cGMP requirements, and internal quality standards.
- Assess, remediate, and strengthen EIDA documentation packages to ensure compliance with regulatory and quality expectations.
- Review, develop, and maintain critical project documentation, including: User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Traceability Matrices, Test Protocols and Validation Documentation
- Provide quality oversight throughout the project lifecycle, including:, Design Review, Construction Support, Commissioning & Qualification (CQV), Validation Activities
- Ensure all project deliverables comply with applicable FDA regulations, GxP requirements, data integrity standards, and internal quality procedures.
- Partner with Engineering, Quality Assurance, Validation, Automation, and Project Management teams to drive compliance and inspection readiness.
- Identify compliance gaps, documentation deficiencies, and quality risks while implementing effective remediation strategies.
- Support audit and inspection readiness activities by ensuring documentation completeness, traceability, and regulatory alignment.
- Provide guidance on regulatory interpretation and quality requirements to project teams and stakeholders.
- Participate in risk assessments, deviation investigations, CAPA activities, and change control processes as required.
- Promote continuous improvement initiatives related to quality systems, compliance processes, and project execution.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Pharmaceutical Sciences, or a related technical discipline.
- 8 years of experience within pharmaceutical, biotechnology, or other highly regulated GxP environments.
- Strong experience supporting quality compliance activities for EIDA systems, automation projects, or regulated manufacturing systems.
- Comprehensive knowledge of: FDA Regulations, 21 CFR Part 11, cGMP Requirements, Data Integrity Principles, Validation Lifecycle Methodologies, Quality Management Systems (QMS)
- Demonstrated experience supporting project lifecycle activities from design through CQV and validation.
- Experience authoring, reviewing, and remediating regulated documentation within pharmaceutical manufacturing environments.
- Strong understanding of audit readiness, regulatory inspections, deviation management, CAPA, and change control processes.
- Excellent communication and stakeholder management skills with the ability to work effectively across multiple functional groups.