QA/RA Documentation Specialist

Allied Medical LLC; Earth City (MO); On-site; USD 42,000 - 62,000; Full time

Job summary

Allied Medical LLC is seeking a Quality Documentation Specialist to own document control and change control processes, ensuring records are organized and readily accessible. The role supports regulatory submissions, training coordination, and QA activities to maintain compliance with 21 CFR 820, ISO 13485, and related standards.

The position involves scanning, filing, and transitioning to a paper-less system, along with data analysis for KPI reporting and continuous process improvement.

Qualifications

• 0-3 years’ experience in regulated industry.
• Experience with scanning, sorting and creating organized filing structures.
• Experience with MS Word, Excel, PowerPoint, Access and Adobe software.
• Excellent written and verbal communication skills.
• Excellent organizational skills and detail oriented.
• Legally authorized to work in the United States.
• Organization
• Strong written and verbal skills
• Collaboration skills
• QA process skills
• Computer knowledge and skill

Responsibilities

• Owns document control functions of change control; ensures records are defined, categorized, maintained, and implemented per document type.
• Scans files and organizes filing structures; supports transition to paper-less system for record control.
• Supports regulatory with creating templates and providing product documentation for submissions and registrations.
• Documents and tracks Nonconforming materials, dispositions and closures.
• Coordinates training document coordination and management; builds tools for training capture and materials.
• Owns Software Validation process; Intake, recording, and assisting software owners with validation SOPs.
• Supports QMS sustaining activities and SOP/WI completion.
• Coordinates reporting/analysis of quality data and resolution of material and product quality issues.
• Drives continuous improvements by recommending changes with relevant teams.
• Assists data collection and analysis for KPI reporting; supports site quality system activities for compliance with 21 CFR 820, ISO 13485, EU MDR, MDSAP.
• Conducts internal audits and documents audit findings; supports corrective/preventive actions.

Skills

Document control

Change control

Regulatory templates

Nonconforming materials

Training coordination

Software validation

QMS sustainment

Data reporting

Process improvement

KPIs analysis

Regulatory compliance

Internal audits

Education

BA/BS in quality, eng, IT/Software

Tools

MS Word

Excel

PowerPoint

Access

Adobe

Job description

Description

• Owner of document control functions of change control by ensuring that records are readily available, properly defined, categorized, maintained, and implemented according to the document type.


• Scanning files and dictating the organization of the file structure to establish a consistent place for the organization to pull records and procedures from. Support the shift to a paper-less system for record control.


• Supporting regulatory with creating templates and providing relevant product documentation for submissions and registrations


• Support the documentation and tracking of Nonconforming materials, dispositions and closures.


• Training document coordination and management. Building tools (electronic and paper) to drive training capture, performance and materials for departments to utilize


• Software Validation process ownership.Intake, recording, assisting software owners with validation expectations per the SOPs in place


• Guide QMS sustaining activities through active completion of Standard Operation Procedure and Work Instruction expectations.


• Coordinate the reporting/analysis of quality data and resolution of material and product quality issues


• Improve process quality by making recommendations for change while working with relevant teams and departments to improve processes


• Drive continuous improvements in all areas, focusing on key performance indicators


• Support data collection and analysis for reporting on key performance indicators


• Support site quality system activities to ensure compliance with international Regulations and Standards, including but not limited to 21 CFR 820, ISO 13485, EU MDR, and MDSAP requirements


• Conduct internal audits, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.

Requirements

Required

• 0-3 years’ experience in regulated industry


• Experience with scanning, sorting and creating organized filing structures


• Experience with MS Word, Excel, Powerpoint, Access and Adobe softwares


• Excellent written and verbal communication skills.


• Excellent organizational skills and detail oriented


• Legally authorized to work in the United States.


• Organization


• Strong written and verbal skills


• Collaboration skills


• QA process skills


• Computer knowledge and skill

Preferred

• BA or BS degree in quality, engineering, or IT/Software discipline


• Experience with quality quality processes and tools


• Knowledge of safety requirements and legal standards


• eQMS skills


• Knowledge of ISO 13485, MDSAP, 21 CFR 820, MDR 2017/745


• Quality Specialist (ASQ or similar Certifications)