Documentation Specialist (m/w/d)

Role Overview

Join a dynamic, fast-paced biopharmaceutical environment to support the Manufacturing Operations team. This position offers significant development potential, with responsibilities tailored to align with your qualifications and professional ambitions. You will work at the local site in close alignment with global Metrology & Validation and Compliance teams, ensuring a state of permanent inspection readiness.

Team Context

The Metrology & Validation team oversees all laboratory instrumentation and equipment, providing daily hands-on support, managing scheduled maintenance and calibrations, and qualifying new analytical instrumentation and Computer Systems projects within a GMP environment. The Compliance team manages all employee training and compliance-related documentation, playing a key role in maintaining regulatory compliance and ensuring document accessibility in accordance with ALCOA+ principles.

Key Responsibilities

• Provide day-to-day support to the Metrology & Validation and Compliance teams by managing documentation storage and archival.
• Develop a digital documentation management process to ensure quick and reliable accessibility to documentation at a moment’s notice.
• Archive documentation in alignment with the company’s record retention requirements.
• Support site-wide projects and initiatives directly related to Metrology & Validation, Compliance, and/or PADT.

Day-to-Day Activities

• Manage the consistent flow of documentation resulting from day-to-day metrology, validation, and compliance business, including Preventative Maintenance, Operational Qualification Documentation, and training files.
• Build or reconfigure a digital documentation management system to establish an easy-to-navigate solution for querying documentation.
• Archive and store documentation within the documentation management system, ensuring it is done according to the company’s record retention policies.
• Coordinate with cross-functional teams and quality departments to ensure compliance with the documentation management process.

Qualifications

Required Education

Candidates must possess one of the following educational backgrounds:

• Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance, or related areas.
• University degree in Biotech, Pharmaceutical industry, Quality Assurance, Regulatory Compliance, or related areas.

Preferred Qualifications

• Strong oral and written communication skills in English (B1) and German (B2).
• Strong documentation skills on technical documents with high attention to detail.
• Demonstrated ability to take initiative and solve problems innovatively in collaboration with other team members.
• Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment.
• Daily communication and coordination with multiple teams to support maintaining documentation onsite.

Advantages

• Experience with project management methodologies, software, or tools.
• Experience in a GMP environment, especially in GMP laboratories.
• Experience in Auditing and Compliance within the pharmaceutical industry.
• Thorough understanding of GMP policies and procedures and proven experience working with Quality.

Position Details

• Contract duration: 12-month contract position, planned to start 13.10.2026 till 12.04.2027.
• Type of employment: Temporary staffing.
• Location: Schachen.
• Working type: Onsite.
• Typical start time: Between 7:00 and 8:45 am.