QA and Data Integrity Consultant

Hyper Recruitment Solutions Ltd; North Carolina; Hybrid; USD 110,000 - 150,000; Full time

Job summary

Hyper Recruitment Solutions Ltd is seeking a Senior Consultant, Quality Compliance & Data Integrity to join a leading pharmaceutical manufacturing organization in North Carolina. The role focuses on retrospective data integrity reviews for sterile products, ensuring robust compliance with GMP and ALCOA+ standards.

You will review qualification and validation documentation, identify data integrity gaps, and support FDA remediation efforts.

Qualifications

• Degree or higher in Pharmaceutical Science, QA, or Quality Management.
• Extensive pharma/GMP experience, preferably in sterile manufacturing.
• Strong data integrity and quality compliance expertise.
• Knowledge of ALCOA+, 21 CFR Part 11, CAPA.

Responsibilities

• Conduct retrospective GMP documentation and data reviews.
• Review qualification and validation docs for equipment, systems, utilities.
• Evaluate records per ALCOA+, FDA cGMP, and Data Integrity.
• Support investigations, root cause analysis, and remediation.

Skills

Data Integrity

ALCOA+

FDA 21 CFR Part 11

GMP

CAPA

FDA remediation

Retrospective data reviews

Quality Compliance

Education

Bachelor's degree in Pharmaceutical Science/QA/Quality Management

Job description

ROLE OVERVIEW

We are currently looking for a Senior Consultant, Quality Compliance & Data Integrity to join a leading pharmaceutical manufacturing organization based in our client's location. This is an exciting opportunity for a seasoned professional with a passion for maintaining the highest standards in GMP environments and ensuring robust data integrity practices. In this role, you will play a pivotal part in supporting compliance and quality assurance activities, specifically focusing on retrospective Data Integrity reviews for sterile products’ manufacturing. Your expertise will be essential in safeguarding product quality and sterility, contributing to industry-leading standards.

KEY DUTIES AND RESPONSIBILITIES

• Conduct comprehensive retrospective reviews of GMP documentation and historical data to ensure ongoing compliance.
• Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, and associated records.
• Evaluate records and data in accordance with ALCOA+, FDA cGMP, and Data Integrity requirements.
• Identify potential data integrity, GMP, and compliance gaps, and assess their impact on product quality and sterility assurance.
• As the Senior Consultant, you will support investigations, root cause analysis, and remediation activities related to FDA 483 observations, ensuring all findings are meticulously documented in an inspection-ready format.

ROLE REQUIREMENTS

• A Degree or higher level in a relevant field (e.g., Pharmaceutical Science, Quality Assurance, or Quality Management).
• Extensive pharmaceutical/GMP experience, preferably within sterile manufacturing environments.
• Strong expertise in Data Integrity and Quality Compliance, with proven experience in retrospective data reviews and FDA remediation.
• Strong understanding of ALCOA+, 21 CFR Part 11, GMP documentation, deviations, investigations, and CAPA.

WHAT’S IN IT FOR YOU?

This role offers an excellent opportunity to work within a dynamic and compliant environment, supporting critical activities in pharmaceutical manufacturing. You will have the chance to influence compliance strategies, contribute to FDA remediation efforts, and make a tangible difference in ensuring product sterility and quality. Our client values professional growth and offers an engaging environment where your expertise will genuinely make an impact.

Key Words: Senior Consultant / Quality Compliance / Data Integrity / Pharmaceutical / GMP / Sterile Manufacturing / FDA Remediation / ALCOA+ / 21 CFR Part 11 / Validation / CAPA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.

HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.