Quality Specialist I, QA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom : no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)

Job Description

General Summary :

The Quality Specialist I ensures that the sites quality management system (QMS) is successfully implemented and maintained. They support audits inspections and reviews to verify compliance with applicable site standards and internal requirements. Additionally they analyze quality data identify areas for improvement and collaborate with various departments to improve overall product and process quality.

Models our 4i values : Integrity Innovation Intensity and Involvement. Aligns with our Quality Policy by continuously improving the quality of our products and services and by ensuring global regulatory compliance.

Essential Functions :

• Responsible for QMS support including document control and record retention training change management and site audits.
• Accountable for Site Training Program.
• Host train-the-trainer sessions for internal subject matter authorities.
• Performs regular assessments of the sites training effectiveness. Where applicable build quarterly and / or annual training programs.
• Use known education principles and stay up to date on new training methods and techniques
• Collaborates with managers / supervisors to assure current curriculum and training records of site departments and their employees.
• Support the review and approval of the master Manufacturing Control Cards (MCCs)
• Responsible for the issuance and management of all departmental logbooks at the site
• Supports the evaluation and review of label design requests ensuring compliance
• Leads and coordinates New Employee Orientation activities to include arranging trainer schedules during onboarding.
• Participates in the site internal / external audits. Works with customers to ensure timely closures of audit commitments.
• Responsible for Site Support for the Learning Management System (LMS) to include :
• Credit entries / granting
• Instruction led course creation
• Metrics
• Curricula creation / modification
• Assignment profile creation
• Updates to curricula
• Extension of due dates when approved
• OJT creation revision and completion updates
• Additional duties as assigned by the supervisor / manager.

Additional Information :

i) Context / Environment :

General - Physical and Environmental Requirements :

iii) Essential Knowledge Skills & Experience :

Knowledge and Experience

Skills

Required Experience :

IC

Key Skills

Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

Employment Type : Full-Time

Experience : years

Vacancy : 1