Job Title: Quality Assurance (QA) Consultant – Pharmaceutical Documentation & CMC Review
Location: Remote / On-site (as needed)—Burtonsville, MD
Regulatory Compliance and QA Oversight
Assess quality systems for adherence to regulatory standards, including 21 CFR Part 11, Part 210/211, and applicable guidance for small molecule drug products.
Provide written QA summaries, gap assessments, and recommendations for remediation.
Assist in maintaining audit trails and inspection readiness for internal and external reviews.
Project-Based QA Support
Collaborate with CMC, regulatory, and manufacturing teams during development and tech transfer projects.
Support the QA review of protocols (e.g., stability, method transfer, process validation) and reports.
Continuous Quality Improvement
Recommend and support implementation of QA process improvements.
Identify trends or recurring issues in documentation or quality control processes and propose corrective actions.
Qualifications
Work Schedule & Compensation
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