Zenith LifeScience · 22 hours ago
Quality Systems Specialist
Exton, PA
Contract
Onsite
Mid Level
3+ years expZenith LifeScience is seeking a Quality Systems Specialist to perform core regional quality systems activities. The role involves developing and revising quality system SOPs, conducting analysis of quality metrics, and supporting project management to drive quality outcomes.
Clinical TrialsConsultingLife SciencePharmaceuticalProduct Research
Responsibilities
Perform core regional quality systems activities as assigned (e.g., revising procedures; assisting in inspection readiness) following defined procedures
Develop, improve, and revise regional quality system SOPs
Conduct ongoing analysis and reporting of key quality and risk metrics and required actions
Monitor and identify gaps within quality systems area and escalate for appropriate action
Support project management for programs/ projects within quality systems area, and communicate with cross-functional teams within site/ area to drive quality outcomes
Qualification
Required
Bachelor's degree, preferably in chemistry, biochemistry, or equivalent technical discipline with 3+ years of experience relevant to role (e.g. auditing and regulatory inspections; learning management systems/ training operations; document control processes; electronic quality systems)
Experience in compliance with cGMPs and relevant health authority and Eisai regional guidelines
Experience in execution of quality processes within own quality systems area (e.g., SOP and protocol writing, metrics monitoring), and assisting in resolution of issues
Proven performance in earlier role
Works as a collaborative player and effectively seeks/ conveys understanding of diverse viewpoints
Communicates with colleagues across levels as needed and influences for the best outcomes
Presents information(written and verbal) in a clear, well thought out way and tailored to the audience
Escalates issues/problems and seeks support in a timely manner
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