CMC Quality Documentation Specialist (100% Remote)

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a CMC Quality Documentation Specialist on a contract basis to support our Customer's business needs. This role is 100% remote.

Responsibilities:

• Perform detailed quality review of CMC documentation, including specifications, batch records, validation documentation, stability protocols and reports, and technical reports
• Review GMP documentation to ensure compliance with FDA, EMA, ICH, and other applicable global regulatory requirements
• Identify documentation gaps, inconsistencies, and compliance risks, and recommend corrective actions
• Support QC documentation review activities related to analytical methods, test records, and data packages
• Provide documentation and quality review support for technology transfer activities
• Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies
• Support inspection readiness by ensuring CMC and GMP documentation is accurate, complete, and audit-ready
• Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC documentation
• Review CMC and GMP documentation produced by CDMOs, testing laboratories, and external partners
• Provide clear and practical documentation feedback to vendors to support compliance and quality improvements
• Collaborate with CMC, Quality Assurance, Regulatory Affairs, and external partners to ensure documentation quality and regulatory alignment

CMC Quality Documentation Specialist – Reviews CMC and GMP manufacturing documentation (batch records, validation reports, stability protocols, etc.) to ensure compliance with FDA, EMA, and global regulatory standards.

Skills and Qualifications:

• Experience reviewing CMC documentation, including specifications, validation records, stability protocols, and technical reports
• Knowledge of GMP documentation standards and global regulatory requirements, including FDA, EMA, and ICH guidelines
• Strong analytical skills with the ability to identify documentation gaps and compliance risks
• Experience supporting QC documentation reviews, including analytical methods, test records, and data packages
• Experience working with CDMOs, contract testing laboratories, or other external manufacturing partners
• Experience supporting regulatory inspections and inspection readiness activities
• Experience supporting technology transfer documentation processes
• Experience supporting investigations related to deviations, OOS/OOT results, and documentation discrepancies
• Ability to provide clear documentation, feedback, and collaborate effectively with internal teams and external partners
• Strong written and verbal communication skills
• Strong attention to detail and organizational skills

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.