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The Technical Operations Specialist is an entry-level role responsible for supporting technical and operational activities in a fast-paced GMP environment. The position focuses on documentation management, project coordination, repository management, and cross-functional collaboration to ensure operational efficiency and compliance.
Bachelor's degree preferred; equivalent experience will be considered.
1–3 years of relevant experience.
Candidates without a degree should have 3+ years of related experience.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Experience creating reports, presentations, GMP documentation, and performing basic data analysis.
Strong verbal and written communication skills.
Excellent organizational and project coordination abilities.
Detail-oriented with strong prioritization and time management skills.
Ability to collaborate effectively with cross-functional teams.
Strong analytical and problem-solving skills.
Microsoft Office Suite
Veeva Vault
Adobe
SAP
Document Management Systems
Execute assigned operational tasks while ensuring compliance with GMP requirements.
Maintain and organize GMP documentation and quality records.
Locate, retrieve, and consolidate documents from multiple repositories into a centralized repository.
Generate Product Specification Files prior to packaging operations.
Collaborate with cross-functional teams to collect and manage documentation.
Coordinate documentation activities to support ongoing projects.
Track task progress and follow through to ensure timely completion.
Maintain accurate records of operational activities.
Complete required system and compliance training to maintain uninterrupted access to company repositories.
Support repository management and document lifecycle activities.
Identify and resolve documentation-related issues through analytical problem-solving.
Ensure documentation accuracy, completeness, and compliance with quality standards.
Communicate effectively with stakeholders across multiple departments.
Retrieve and organize documents from various electronic repositories.
Work with document owners across multiple departments.
Consolidate documentation into a single repository.
Manage high-volume documentation in a GMP-regulated environment.
Complete training for multiple Merck systems.
Support documentation requests for packaging and technical operations.
Maintain organized documentation and repository records.
Coordinate with project teams to meet documentation deadlines.
Documentation management in GMP or Quality environments.
Repository and document lifecycle management.
Project coordination.
Cross-functional collaboration.
Quality systems and GMP documentation.
Technical operations support.
Hybrid schedule (3 days onsite).
Strong emphasis on documentation management (GMP & Quality).
High-volume repository management experience preferred.
Self-motivated with the ability to work independently and meet deadlines.
Reliable, detail-oriented, and proactive approach to daily responsibilities.