QC Inspector I- 3rd Shift

SHL Medical; Deerfield Beach (FL); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

Modern facilities

Global team environment

Development opportunities

Drug-free employer

Job summary

SHL Medical in Deerfield Beach, FL, seeks an inspector to support operations by performing inspections and testing, maintaining records, and ensuring quality across materials and products. You will verify line clearance, material verification, in-process controls, and non-conformance investigations, with exposure to ISO 13485, GMP, and FDA compliance.

This role requires 1–2 years of pharma/device experience and an associate degree.

Qualifications

• Associate degree in science or related field preferred.
• 1–2 years in pharma/medical devices or equivalent.
• Experience with inspection tools is a plus.
• Knowledge of ISO 13485, GMP, FDA compliance, CAPA, risk management.

Responsibilities

• Perform quality control inspections and testing for materials and products.
• Inspect in-process materials and finished products per procedures.
• Conduct product identification and traceability activities.
• Support device testing for stability studies and validations.
• Report nonconformances and assist with CAPA and QMS documents.

Skills

Quality inspection

GMP knowledge

ISO 13485

Documentation practices

Microsoft Excel

Education

Associate Degree in Science

High School Diploma or GED

Tools

Inspection tools

Microsoft Word

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
• Segregates nonconforming materials per applicable procedures.
• 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-arts 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