Documentation Specialist Digital Operations
Job Location:
Monthly Salary:
Experience Required:
Posted on:
19 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
We are seeking a Documentation Specialist for Digital Operations to support manufacturing documentation activities including processes supported by the Tulip platform. This role is responsible for developing reviewing and maintaining controlled documents that support compliance traceability and operational excellence in a regulated manufacturing environment.
Key Responsibilities
- Develop review and maintain manufacturing and digital documentation including SOPs digital work instructions work instructions batch records and equipment maintenance logs.
- Ensure documentation is current accurate properly controlled and aligned with regulatory requirements GMP/GxP standards internal quality procedures and approved digital workflows.
- Support the creation and maintenance of controlled documents for product specifications testing protocols design history files and digitized manufacturing processes.
- Maintain compliance with data integrity principles such as ALCOA and internal quality standards ensuring traceability between approved documents and digital execution tools.
- Partner with Quality Assurance Manufacturing Engineering and Digital Operations teams to ensure documentation and workflows meet company policies and industry regulations.
- Assist with internal audits document reviews and inspection readiness activities by providing documentation support and traceability evidence aligned with regulatory and ISO standards.
Requirements
- Bachelors degree in science engineering quality or related technical field.
- Experience in regulated manufacturing environments such as pharmaceutical biotechnology or medical devices.
- Working knowledge of GMP/GxP requirements document control practices and data integrity principles such as ALCOA.
- Strong attention to detail technical writing skills and the ability to work cross-functionally with multiple departments.
- Experience supporting digital manufacturing systems or electronic documentation platforms are preferred.
Required Skills:
Associate or Bachelors degree in Environmental Science Environmental Technology Chemistry Industrial Safety or related field. Experience: 3-5 years of experience in environmental compliance hazardous waste handling or related field; manufacturing or medical device industry preferred. Knowledge of EPA regulations (RCRA SPCC Storm-water/MSGP). Ability to perform fieldwork inspections and sampling activities. Strong attention to detail and documentation accuracy. Basic computer skills (Microsoft Office; environmental software is a plus). Ability to work independently and follow established procedures.
Required Education:
Bachelors degree in Mechanical Engineering (or equivalent).
