Qa Inspector - 2Nd Shift

Department

Quality Assurance

Job Title

Inspector

FLSA Status

Non-Exempt

Reports To

Quality Assurance Supervisor

1. Role Purpose:

Quality Assurance Inspector’s ensures that products manufactured meet industry and federal standards, and to make the entire manufacturing process more efficient.

2. Key Duties & Responsibilities:

• The Quality Assurance Inspector ensures that all products manufactured at KVK TECH facility are manufactured in accordance with current Good Manufacturing Practices (GMP) and also meet all internal specifications
• This position will spend the majority of their time on the shop floor providing oversight and guidance to manufacturing personnel in the performance of their duties
• This position is also responsible for performing a number of manual and automated quality assurance checks on in-process products and finished goods
• This position is responsible for reviewing documents to ensure that they were completed in accordance with current GMP and site SOPs
• Strong organizational skills and the ability to prioritize work and respond to customer demands in a timely fashion are critical requirements of this position
• Other duties, responsibilities and qualifications may be required and/or assigned as necessary.
• Comply with FDA guidelines/Company Policies of Data Integrity.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

2-year certificate in a scientific discipline from an accredited college or technical school preferred

5. Technical competencies/ Certifications/ Licenses:

• Review documents to ensure they meet GMP and site SOP requirements.
• Identify, investigate, and prepare reports on quality issues.
• Perform line clearance, inspections, and physical testing in manufacturing areas.
• Interpret generated data and communicate results to Quality management.
• Maintain effective communication and partnership with Operations and Materials Management department.
• Adapt to changes in the work environment and must be able to change shifts or work overtime and/or weekends, as needed.
• Ability to read, write and interpret documents such as batch records, SOPs, and Process Protocols and Reports.
• QA experience in a manufacturing environment preferred.
• Ability to demonstrate accuracy and thoroughness while completing work in a timely manner.
• Strong attention to detail and organizational skills.
• Effective interpersonal and communication skills.
• Follows instructions, policies, and procedures.

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A