Zenith LifeScience · 1 month ago
Compliance Specialist CMC
Westborough, MA
Contract
Onsite
Mid, Senior Level
6+ years expZenith LifeScience is a company focused on ensuring quality and compliance in the pharmaceutical and biotechnology sectors. The Compliance Specialist CMC will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and regulatory submissions, fostering data integrity and quality across various areas of Quality Assurance.
Clinical TrialsConsultingLife SciencePharmaceuticalProduct Research
Hiring Manager
Amita Chandidas
Responsibilities
Performs QA review of executed development studies intended for regulatory submissions, included 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
Qualification
Required
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
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
Company
Zenith LifeScience
Zenith LifeScience is a consulting company that specializes in clinical trials, research, pharmacovigilance, and regulatory compliance.
51-200 employees
H1B Sponsorship
Zenith LifeScience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (21)
2024 (10)
2023 (3)
2022 (14)
2021 (4)
2020 (4)
Funding
Current Stage
Growth StageCompany data provided by crunchbase