Job Description

Job Title: Quality Assurance (QA) Consultant – Pharmaceutical Documentation & CMC Review

Location: Remote / On-site (as needed)—Burtonsville, MD

• Key ResponsibilitiesCMC and Laboratory Documentation Review
• Review batch records, method validations, specifications, CoAs, and manufacturing protocols for compliance with cGMP, FDA, and ICH guidelines.
• Ensure laboratory notebooks, analytical reports, and SOPs are complete, accurate, and compliant.
• Evaluate quality documentation for consistency, traceability, and audit readiness.

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

• Bachelor’s degree or higher in Chemistry, Biology, Pharmacy, or a related scientific discipline.
• Minimum 5 years of pharmaceutical industry experience in Quality Assurance, with specific experience in CMC documentation review.
• Working knowledge of FDA, ICH, and cGMP regulatory requirements.
• Strong analytical and documentation review skills.
• Excellent verbal and written communication skills.
• Ability to work independently and meet project deadlines in a remote or hybrid setting.
• Experience working with contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) is preferred.

Work Schedule & Compensation

• Hours: Flexible; based on project timelines and deliverables
• Compensation: Competitive hourly rate, invoiced per project
• Work Environment: Remote with potential site visits (if required); collaborative with QA, CMC, and regulatory teams

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