About Company
At Ennovi we harness the power of two megatrends - electrification and AI - to help industries innovate at speed, operate smarter, and achieve sustainable growth. By combining these transformative forces with our global reach and best talent, we empower our customers to lead their markets and drive sustainable progress.
From automotive and aerospace to consumer electronics, data storage, industrial, and medical markets, we harness these forces to help our customers create smarter, safer, and more sustainable solutions.
We thrive best in developing high-performance custom solutions that meet diverse technical needs, solve unique challenges, optimize performance, and adapt to evolving market demands.
Our mission is to get customers to the future faster, from anywhere. Headquartered in Singapore, ENNOVI has a global presence across North America, Europe, SEA and China, where all its activities are socially responsible, with minimal environmental impact. Learn more at www.ennovi.com.
Ennovi is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non-discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.
Why Join Us
At Ennovi, we envision a future of electrification and innovation and strive to create an inspiring workplace where our employees are integral to shaping that future. We offer a dynamic, collaborative and inclusive culture that encourages continuous learning, professional growth, and a sense of purpose. As a part of the Ennovi team, employees experience the excitement of being at the forefront of cutting-edge technologies and contributing to a sustainable future.
Our commitment to the transformation is epitomized by our five pillars: Speed, Innovation, Best Talent, Global Reach, and Sustainability. This entails navigating exponential market changes through agile structures, fostering innovation across all aspects of our business, strategically expanding our global footprint, championing sustainability initiatives and nurturing a winning team.
Privacy Policy
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Position Overview
A Document Clerk in a medical component manufacturing company is responsible for managing, organizing, and maintaining the organization’s critical documentation in compliance with strict regulatory and quality standards. This role supports quality, regulatory, and operational processes by ensuring that all records are accurate, accessible, and up to date.
Core Purpose
The document clerk ensures that all controlled documents — such as Standard Operating Procedures (SOPs), batch records, validation protocols, and regulatory submissions — are properly versioned, stored, and retrievable. The role is essential for maintaining compliance with FDA, cGMP, and ISO requirements, and for supporting audits, inspections, and quality monitoring
Main Responsibilities
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Partner with Quality Assurance and Document Control teams to manage controlled documents.
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Maintain electronic and physical document control systems, ensuring proper versioning, access, and security.
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Receive, log, and organize all incoming and outgoing documentation related to production, quality, and regulatory processes.
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Prepare, review, and distribute controlled documents, including SOPs, batch records, and validation protocols.
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Support audits and inspections by providing accurate and timely retrieval of documentation.
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Track document revisions, approvals, and expiration dates to keep records current.
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Coordinate with cross-functional teams to facilitate timely submission, review, and approval of documents.
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Generate reports and metrics to support management oversight and quality monitoring.
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Ensure strict compliance with company policies, cGMP, FDA, and ISO requirements
Job Requirements & Qualification
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Associate’s degree or higher in Life Sciences, Business Administration, or a related field.
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2–5 years of experience in document control or clerical support in a regulated pharmaceutical or biotech environment.
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Knowledge of cGMP, FDA, and ISO documentation standards.
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Proficiency with electronic quality Management Systems (eQMS) and Microsoft Office Suite.
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Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
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Preferred: Experience with eDMS platforms like QT9, Veeva Vault or MasterControl, exposure to regulatory submissions, validation documentation, or quality audits
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Preferred: Bilingual (English, Spanish)
