Compliance & Documentation Specialist

Compliance and Documentation Specialist develops, establishes, and maintains the Engineering Documentation System in a manner that ensures all identified technical documentation is inventoried and available to reflect the accurate status of all current equipment and engineering processes.

Will develop, establish, and maintain engineering documentation policies, processes, procedures, and controls; ensuring that the system and documents conform to established standards and agency guidelines.

Track documentation through the full life cycle process.

Drive accountability for all quality related Engineering documentation (CRs, CAPAs, SOPs, etc.) to ensure good documentation practices and timely action closure.

Duties and Responsibilities


* Provides oversight and guidance to sustain compliance with Regulatory, Corporate and Site processes for Engineering documentation, which includes all change controls, validation, commissioning, deviation, SOPs, capital project files, and drawings, and engineering turn over packages.


* Accurately maintains the controlled filing storage systems for current and historical records.


* Develops and maintains appropriate policies and/or procedures to be applied to all Engineering documentation regardless of source, location, or media type.


* Controls lifecycle documents within scope of department such as CRs, SOPs, forms, technical reports, Validation Protocols and Reports, and drawings.


* Establishes and maintains the Drawing Management System.


* Responsible for the coordination, control, storage, copying and retrieval of all Engineering documentation.

Develops, classifies, and reviews record retention schedules for Engineering Documentation.

Periodically reviews and updates retention schedules to reflect changes in legal and/or operational requirements.


* Maintains database tracking system for Engineering Documentation.


* Audits Engineering SOP's, document types, and training records to ensure compliance.


* Participates in all inspections and internal / external audits by facilitating document access as assigned.


* Coordinates and tracks all department EHS and Quality actions.


* Functions as lead deviation writer for the Engineering department.

Education, Experience, and Skill Required


* Bachelor's degree preferred; associate degree accepted with 3-5 years industry experience.


* 3-5 years' experience in technical writing, QA/QC documentation background.


* Experience with document and drawing management processes.


* Ability to work within standard operating procedures with moderate supervision.


* Experience in an engineering environment a plus.


* Fluent in written and spoken English.

Pay & Benefits

Salary Range: $65,500 - $107,000 per year; depending on experience.

Sotera Health offers a competitive benefits package that includes:


* Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending ...