Quality Assurance Tech (Night shift)

CCL Label Inc.; Sioux Falls, Northern (SD, KY); Hybrid; USD 42,000 - 60,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match up to 8%

Life insurance

Tuition reimbursement

Job summary

CCL Healthcare Sioux Falls is seeking a Quality Assurance/Manufacturing Associate to support standard processes and ensure compliance with quality standards in a fast-paced production environment. The role involves assisting with inspection, testing, and documentation to maintain conformance with GMP requirements.

You will collaborate with production teams, perform product release tasks, and participate in audits.

Qualifications

• HS diploma or GED or equivalent.
• 6+ months manufacturing experience preferred.
• Able to stand, walk, and lift up to 50 pounds.

Responsibilities

• Performs approval and final release of products per customer specs.
• Inspects finished products, raw materials, and equipment for GMP compliance.
• Performs First Article and Retention Sample digital comparisons for copy integrity.
• Completes GMP housekeeping and job ticket documentation audits.
• Ensures sample inspections meet specifications and timelines.
• Prepares Certificates of Compliance and Certificates of Analysis.

Skills

Teamwork

Safety awareness

Attention to detail

Reliability

Willingness to learn

Education

HS diploma or GED

Job description

Job Highlights

Who is CCL Healthcare?

CCL Healthcare, a division of CCL Label, is focused on producing secondary packaging within cGMP facilities. We pride ourselves in partnering globally with companies of all sizes and manufacturing our products locally to our partners. That is why we have 29 cGMP facilities worldwide and are growing. With over 65 years of printing experience, CCL Healthcare knows quality matters. That is why we have invested heavily into 100% Vision Inspection Systems and deployed the most rigorous Quality Assurance process in the industry. What does this mean for our partners? CCL Healthcare is dedicated to providing our partners with the lowest cost of ownership in the industry. Our products are designed to increase packaging line throughput, minimize the investment in equipment, and deliver the highest quality products on the market.

What do we do?

CCL Healthcare is the largest global manufacturer of high-quality pharmaceutical labels, literature, digital folding cartons and specialty packaging components that ensure complete compliance with FDA-mandated requirements.

Our product line includes:

• Folding Cartons
• Printed Literature
• Expanded Content Labels
• RFID Labels
• Multi-ply Labels
• Pressure Sensitive Labels
• Smart Packaging

We make packaging solutions for:

• Pharmaceutical Rx
• Biotechnology
• Contract Pharmaceutical
• Generic Pharmaceutical
• Pharmaceutical OTC
• Medical Device
• Clinical
• Animal Health

Join the team at CCL Healthcare Sioux Falls

We are looking for candidates who have a great attitude and a desire to learn a career in a fast-paced environment. We have several manufacturing positions available with on-the-job training provided.

What we offer

CCL offers a 4-day work week in our production departments with night shift available. We have an extensive benefits package that includes: vacation and paid personal off, health, dental and vision insurance, 401(k) match up to 8%, company-paid life insurance and disability insurance, employee assistance program, flexible spending account, and tuition reimbursement.

Job Summary & Requirements

Job Summary:

Supports quality in standard processes to ensure compliance with standards; works with production team to ensure inspection and testing procedures are implemented and maintained, performs testing and audits of in-process and completes work orders to ensure product conformance.

Supervisory Responsibilities: None

Duties/Responsibilities:

• Performs approval and final release of products based on customer specifications and instructions.
• Inspect finished products, raw materials, supplies, equipment, personnel, and facilities for adherence to quality specifications and current Good Manufacturing Practices.
• Perform First Article and Retention Sample digital comparisons to ensure copy integrity and correctness.
• Completes auditing of GMP, housekeeping and job ticket documentation.
• Ensure that sample inspections are completed accurately within specifications and within established timeframes.
• Compile data for Certificates of Compliance and Certificates of Analysis.
• Other duties as assigned.
• Document defects with conciseness, accuracy, and details to ensure defects are not reproduced
• Calibrating and cleaning of testing equipment.
• Perform tasks assigned by others in a diverse and varied work environment.

Required Skills/Abilities:

• Willingness and ability to work with other team members and management.
• Strong work ethic and good attitude towards work.
• Honest, reliable team player.
• Safety conscious and comply with all general safety policies and procedures in accordance with Company, State and Federal Occupational Safety and Health Administration (OSHA) rules and regulations.

Education and Experience:

• High school diploma, GED or equivalent
• 6 months or more experience in a manufacturing environment (preferred)
• 6 month or more industry experience (preferred)

Physical Requirements:

• Regularly use hands to finger, handle or feel and reach with hands and arms above and below shoulder level
• Regularly stand and walk for extended periods of time
• Regularly communicate in some manner either by speech/hearing or through written communication.
• Regularly use of vision abilities including close, distance, color and peripheral vision, depth perception and the ability to adjust focus.
• Regularly work around moving machinery and heavy equipment
• Frequently required to push/pull.
• Frequently lift and/or move up to 50 pounds.
• Occasionally required to sit; climb or balance; stoop, kneel, crouch, or crawl.
• Frequently exposed to high-speed moving mechanical parts.
• Frequently exposed to UV, strobing or flashing light.
• Occasionally exposed to fumes, dust or airborne particles.
• Regularly exposed to moderate noise level in the work environment.

CCLprovides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment.All qualified applicants will receive consideration for employmentwithout regard to race, color, religion, age, sex, national origin, disability status, genetics,protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.