Compliance Specialist
Zenith LifeScience
Summary
The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Astellas to help ensure high quality standards and value delivery for our patients.
Job description
Job Description
The Compliance Specialist CMC, Quality Assurance will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts at Astellas to help ensure high quality standards and value delivery for our patients.
Responsibilities And Accountabilities
- Performs QA review of executed development studies intended for regulatory submissions, including but not limited to draft batch records, analytical test records, and calibration records to ensure developmental studies are conducted and data collected in compliance with approved protocols, appropriate Corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
- Identifies and reports documentation errors and deviations from Protocols, SOPs or specifications in a timely manner.
- Responsible for communicating QA review, audit results and reporting.
- Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.
Required Qualifications
- 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 Masters degree.
- In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
- Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
Preferred Qualifications
- Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
- Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and exercise sound Quality-by-Design principles.
Requirements
- BS/BA in Life Sciences, Engineering, or Chemistry
- 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree
- In lieu of a Life Sciences degree, minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail
- Working fluency in Microsoft Office productivity suite (including Excel and PowerPoint)
- Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements
- Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions and exercise sound Quality-by-Design principles
Company overview
Zenith LifeScience is a premier Contract Research Organization (CRO) and specialized consulting firm based in South Plainfield, New Jersey, providing comprehensive end-to-end clinical development services to the life sciences and healthcare industries. The company operates as both a consulting firm and contract staffing organization, offering integrated clinical research support and lifecycle management services. Zenith LifeScience leverages innovative technologies and therapeutic expertise to help clients optimize drug development timelines and costs while delivering life-changing therapies. Their core service areas include pharmaceutical validation, regulatory affairs, pharmacovigilance and drug safety, clinical data management, clinical trial operations, quality assurance, and compliance. With a team of 51-200 employees, the company emphasizes quality commitment and invests in professional development to ensure client success. Zenith LifeScience serves as a strategic partner for pharmaceutical and biotechnology companies seeking to accelerate clinical development programs while maintaining regulatory compliance and operational excellence.