Job summary
Job post source
This job is from a recruiting firm hiring for a separate company.
Job overview
The QA Compliance Specialist role at cGxPServe involves ensuring compliance with GMP regulations in a biopharmaceutical environment, focusing on quality assurance and regulatory adherence.
Responsibilities and impact
The specialist will manage QA compliance systems such as Quality Management Review, Annual Product Quality Review, self-inspections, and audit readiness, ensuring adherence to FDA/ICH/EU cGMP regulations and data integrity principles.
Experience and skills
Requires minimum 8+ years in GMP-regulated biopharmaceutical settings with at least 2+ years in QA roles, strong knowledge of QA compliance systems, and understanding of FDA/ICH/EU cGMP regulations and data integrity (ALCOA+).
Company overview
cGxPServe operates in the engineering and information technology sectors, specializing in research services with a focus on manufacturing, process control systems, and clinical data management. The company provides expertise in areas such as supplier quality, regulatory affairs, clinical project management, and data programming, serving clients in highly regulated industries, including medical devices and pharmaceuticals, as indicated by references to ISO 13485 and 21 CFR 820 compliance. cGxPServe generates revenue through professional services and staffing solutions, supporting roles like manufacturing engineers, clinical data managers, and regulatory specialists. With locations in California and North Carolina, the company is positioned to address complex compliance and operational needs for clients. Its history and growth reflect a commitment to supporting quality and regulatory standards in life sciences and advanced manufacturing.
How to land this job
Tailor your resume to emphasize your extensive GMP experience and at least 8 years working in GMP-regulated biopharmaceutical environments, highlighting your QA roles and compliance expertise.
Focus on showcasing your knowledge and hands-on experience with QA Compliance systems such as Quality Management Review (QMR), Annual Product Quality Review (APQR), self-inspections, and audit readiness to align with cGxPServe's requirements.
Apply through multiple platforms including cGxPServe's official corporate website and LinkedIn to maximize your chances of getting noticed by recruiters.
Connect with current QA Compliance or Quality Assurance professionals at cGxPServe on LinkedIn; use ice breakers like asking about their approach to audit readiness or recent challenges in maintaining data integrity standards.
Optimize your resume for ATS by incorporating keywords such as 'GMP,' 'QA Compliance,' 'QMR,' 'APQR,' 'FDA/ICH/EU cGMP regulations,' and 'Data Integrity ALCOA+ principles' to ensure it passes initial automated screenings.
Utilize Jennie Johnson's Power Apply feature to automate tailored resume customization, identify multiple application channels, and facilitate networking connections, allowing you to focus your energy on interview preparation and strategic job search activities.
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