Senior Consultant, CMC / GMP Documentation & Quality Control
Maxonic, Inc.
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Job Details
Skills
- Senior Consultant
- CMC / GMP Documentation & Quality Control
Summary
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Senior Consultant, CMC / GMP Documentation & Quality Control.
Job Description:
Job Title: Senior Consultant, CMC / GMP Documentation & Quality Control
Job Type: Contract
Job Location: California
Work Schedule: Remote
Pay Rate: $180, Based on experience.
Perform detailed quality review of CMC documentation including specifications, batch records, validation documentation, stability protocols and reports, and technical reports.
- Review GMP documentation for 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 QC documentation and quality review support for technology transfer activities, as needed
- Support investigations related to QC deviations, OOS/OOT results, and documentation discrepancies
- Support inspection readiness by ensuring CMC and GMP documentation is inspection-ready, accurate, and complete
- Assist with responses to regulatory questions, inspection observations, and information requests related to CMC and QC topics
- Review CMC and GMP documentation generated by CDMOs, testing laboratories, and other external partners
- Provide clear, practical documentation feedback to vendors to drive compliance and quality improvements
- Collaborate closely with CMC, QA, Regulatory Affairs, and external partners
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Lavanya Dommeti ( / ) for more details.
- Dice Id: 10108942
- Position Id: 8905065
- Posted 11 hours ago
Company Info
Maxonic is a technology consulting firm headquartered in Campbell, CA. The company was founded in 2002. Maxonic founders created new methods from decades of experience in the technical consulting industry and they have successfully invented and applied our unparalleled methodology to help our clients to reach their goals in the most efficient and cost effective way. The founders were focused to build a company that centered around providing superior customer service through strong and lasting relationships. A testament to the success of their vision lies in the fact that all of Maxonic s customers from its first year in business, continue to work with us.
Over the years, the number of our loyal clients has grown from a list of start-ups and small businesses, all the way to the industry giants of the fortune 100.
Since its inception, Maxonic has sought to find ways to improve its service to meet new challenges that face its customers. The Process-Based proactive approach was one such improvement, and evolved from countless hours of research, discussions with clients and statistical evidence. All of Maxonic s service offerings Big Data Services, Cloud Computing Services, Mobility Services and Technical Staffing Services reflect our commitment to creating and enhancing services that help clients meet their toughest challenges.
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