Quality Assurance Associate II
hace 4 días
About the Role:
We are seeking a highly skilled and experienced Senior Quality Specialist to join our team at Marken, a leading provider of temperature-controlled logistics solutions for pharmaceuticals and biologics.
Job Description:
The successful candidate will be responsible for overseeing and implementing the Quality Management System (QMS) at our facility, ensuring compliance with relevant regulatory requirements, including GMP, GDP, and ISO 13485. This role requires strong leadership and coordination skills, as well as excellent communication and interpersonal abilities.
Main Responsibilities:
Develop and implement QMS policies, procedures, and training programs to ensure compliance with regulatory requirementsConduct internal audits and inspections to identify areas for improvement and ensure corrective actions are implementedCollaborate with cross-functional teams to develop and implement quality-related projects and initiativesMaintain accurate records and reports on quality metrics and performance indicatorsIdentify and implement opportunities for process improvements and cost savingsRequirements:
To be considered for this exciting opportunity, you will need to have:
A minimum of 2+ years of experience in a quality assurance role within a regulated industryAn Associate degree or equivalent University Degree/CertificationRelated knowledge of Good Manufacturing Practice, Good Distribution Practice, and Good Storage Practice guidelinesExcellent communication and interpersonal skills, with ability to work effectively in a team environmentFluent in English, with proficiency in Microsoft Office and other software applicationsAbout Marken:
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. We offer a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, as well as cell and gene therapy logistics services from clinical to commercial.
Salary Information:
The estimated salary for this role is $70,000 - $90,000 per year, depending on experience and qualifications.
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