Job Details

Description

SUMMARY

The Quality Technician supports the quality function by providing daily technical oversight to critical steps in the procurement, manufacturing, and documentation in a regulated industry. Representative duties include incoming material inspections, in-process testing, retain and stability sampling and sample management, document review and accountability, and line-side audits.

ESSENTIAL RESPONSIBILITIES

• Participate in inspections of incoming materials following approved specifications and procedures.
• Provide manufacturing quality oversight through line side audits and technical document review.
• Provide guidance to manufacturing for documentation guidelines.
• Participate in line clearance activities including approving start of production lots.
• Collect and manage samples for retain, stability, and in-process sampling of manufactured products.
• Participate in investigation and root cause analysis.
• Provide information and guidance for production leadership.
• Independently prioritize and initiate activities to ensure effective completion of tasks.
  
  

EXPECTATIONS

• Perform duties following company quality and safety standards.
• Participate in team building, training, and department communications.
• Maintain a high level of personal and professional integrity.
• Perform additional job responsibilities as assigned.
  
  

QUALIFICATIONS

Below are the guidelines for education, knowledge, skill, and/or abilities needed to perform each essential duty satisfactorily. Reasonable accommodation will be considered for individuals who are unable to meet the required qualifications.

Required:

• Must have a high school diploma or equivalent.
• 2 or more years of relevant experience working in a controlled environment.
• Must have the ability to build a rapport with all levels of staff.
• Strong verbal, written, organizational, time management and interpersonal skills.
• Experience working with Measuring tools
• Strong organizational skills
• Ability to prioritize tasks and accomplish results independently
• Ability to learn and understand quality philosophies, principles, systems, methods, tools, and standards in a regulated environment.
  
  

Preferred:

• Working knowledge of FDA (21CFR parts 4, 11, 210, 211, & 820), GMP, and ISO 13485.
• A bachelor’s or associate's degree is preferred
• Pharmaceutical or medical device industry experience
• Change Control
• Root Cause Analysis
  
  

Qualifications

0" style="display: none;">

Skills

0">

0">

0" style="display: none;">

Behaviors

0">

0">

:

0" style="display: none;">

Motivations

0">

0">

:

0">

Education

0">

Required

High School or better.

0">

0">

Experience

0">

Required

2 years:

Years of experience working in a controlled/regulated industry (medical device or pharmaceutical manufacturing)?

0">

0" style="display: none;">

Licenses & Certifications

0">

0">

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.