Technical Operations Specialist

Job Title: Technical Operations Specialist
Duration: 12 Months
Location: West Point, PA
Work Environment: Hybrid (3 days onsite; flexible onsite days between Monday-Thursday)

Job Summary

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.

Qualifications

• 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.

Required Skills

• 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.

Preferred Software Experience

• Microsoft Office Suite

• Veeva Vault

• Adobe

• SAP

• Document Management Systems

Key Responsibilities

• 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.

Day-to-Day Responsibilities

• 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.

Preferred Experience

• 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.

Key Notes

• 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.