QC Inspector I- 3rdShift

SHL Medical Assembly&Servc LLC; Deerfield Beach (FL); On-site; USD 52,000 - 74,000; Full time

Job summary

SHL Medical, a world-leading provider in the design, development, and manufacturing of advanced self-injection devices, is seeking an Inspector to support operations through inspections and testing. This role focuses on ensuring quality and compliance across materials and finished products within a rigorous GMP environment.

Based in Deerfield Beach, FL, you will perform in-process controls, material verification, and device testing, maintain documentation, and collaborate with cross-functional

Qualifications

• Experience with inspection tools or equipment used for QA/QC validation.
• Familiarity with FDA quality systems and documentation practices.

Responsibilities

• Perform inspections and testing for materials or products with records.
• Conduct in-process controls and line clearance per procedures.
• Verify material identification and traceability (e.g. quarantine).
• Perform device testing to support product realization, stability, and validations.
• Notify management of nonconforming material or test failures.
• Ensure compliance with quality, safety, and work rules; adapt to varied schedules.

Skills

Inspection tools

Documentation practices

Quality systems knowledge

Education

Associate Degree in Science or related area

High School Diploma or GED

Tools

Microsoft Word

Microsoft Excel

Microsoft Teams

Job description

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

Supports Operations and Development by performing inspections or testing for materials or products, and maintains records documenting the activity.

Main Responsibilities

• Performs quality control activities (Incoming Inspection, Line Clearance, Material Verification, In-process Controls, CCIT, Additional Sampling, and Inspections or Testing) to support SHL Pharma’s manufacturing process, Stability, and ENPs.
• Inspects in-process materials and finished products per applicable procedures, protocols, and/or batch record requirements.
• Performs product identification and traceability activities as required (e.g. Quarantine).
• Performs device testing in support of product realization, stability studies, and validations.
• Notifies management of nonconforming material or test failures promptly
• Checking that the assembly or production line adheres to standards and procedures.
• Assists with the initiation of QMS documents like Non-conformance Investigations.
• Compliance with all quality, safety, and work rules and regulations.
• Must be flexible to work a variety of schedules to meet business needs.
• Perform other related duties as assigned.

Skills and Qualifications

• Associate Degree in Science or related area (equivalent experience will be considered), preferred.
• High School Diploma or GED required
• 1-2 years in the pharmaceutical and/or medical device industry or equivalent
• Minimum 1 year of experience with inspection tools preferred
• Basic Knowledge of ISO 13485, GMP, FDA Compliance, CAPA, and Risk Management
• Knowledge and experience conducting laboratory analyses supporting FDA-regulated products (i.e. physical, functional, or chemical analyses)
• Knowledge and experience working with sampling plans.
• Knowledge of Good Documentation Practices
• Knowledge of Good Manufacturing Practices
• Proficient in the use of Microsoft Products (Word, Teams, Excel
• Ability to lift 20lb boxes and work in refrigetators for short period of time
• Ability to sit and talk or hear
• Ability to stand, walk, use hands to finger, handle or feel objects
• Ability to reach with hands and arms
• Able to work from 9:00PM-5:30AM

We Offer

• Competitive compensation package
• Modern working environment with state-of-the‑art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com