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 site's 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 site’s 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:

• Must be able to work safely with materials and equipment.
• May be exposed to fumes and chemicals such as raw materials, cleaners, etc. 
• Support 24 hours, 5 days a week operation. Overtime/Off Shift On-site support may be required.
• Various levels of gowning may be required. 

iii) Essential Knowledge, Skills & Experience:

Knowledge and Experience

• High School Diploma or equivalent.  Preferred: Bachelor’s degree in a technical field. 
• Minimum of 3 years experience in a Quality Systems or related role.
• Knowledge of cGMPs, standards and regulations such as ISO 9001.

Skills

• Models personal accountability and integrity. 
• Experience with learning management software. 
• Interpersonal skills with the ability to prioritize multiple assignments. 
• Proficiency in MS Office and database software. 
• Excellent time management, communication, decision-making, organization, and social skills. 
• Possesses strong customer service skills, interpersonal and communications skills.