Compliance Specialist
Job Responsibilities:
- Perform QA review of executed GMP analytical batch records, in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, and procedures.
- Review executed development studies intended for regulatory submissions, including draft batch records, analytical test records, and calibration records, ensuring compliance with approved protocols, corporate guidelines, internal procedures, and global regulatory standards.
- Identify and report documentation errors and deviations from test/data records, protocols, SOPs, or specifications in a timely manner.
- Collaborate with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written, technically sound, and supported by evidence.
Skills:
- Working fluency in Microsoft Office (Excel, PowerPoint, Word)
- Attention to detail, strong technical aptitude, and ability to make objective, risk-based decisions
- Knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements (preferred)
- Ability to interpret regulatory rules, guidance, and industry standards
Education/Experience:
- BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years of related Quality Assurance experience within GMP-regulated industry, or 1–2 years with a Master’s degree
- Candidates without a Life Sciences degree may be considered with 6+ years of industry experience in biotechnological/pharmaceutical quality, manufacturing, or other technical fields requiring high attention to detail
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