QC Inspector I- 3rdShift

SHL Group; Deerfield Beach, Northern (FL, KY); Hybrid; USD 42,000 - 60,000; Full time

Job summary

SHL Medical is seeking a Quality Control Inspector to support operations and development by performing inspections, testing, and maintaining records for materials and products. You will inspect materials and finished products, perform product identification and traceability, and support stability studies and validations in a fast-paced manufacturing environment.

The role requires 1–2 years in pharma/medical devices, knowledge of ISO 13485 and GMP, and the ability to work a 9:00 PM to 5:30 AM

Qualifications

• Associate degree in science or related area; equivalent experience considered.
• High school diploma or GED required.
• 1-2 years in pharmaceutical or medical device industry or equivalent.
• Minimum 1 year of experience with inspection tools preferred.
• Knowledge of ISO 13485, GMP, FDA compliance, CAPA, and Risk Management.
• Knowledge/experience conducting laboratory analyses supporting FDA-regulated products.
• Knowledge of sampling plans.
• Good Documentation Practices and Good Manufacturing Practices.
• Proficient with Microsoft Word, Teams, and Excel.
• Ability to lift 20 lb and work in refrigerators briefly.

Responsibilities

• Performs quality control activities to support SHL Pharma's manufacturing process, Stability, and ENPs.
• Inspects in-process materials and finished products per applicable procedures, protocols, and batch records.
• 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.
• Segments 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

Quality control

Documentation

Regulatory knowledge

Microsoft Office

Physical inspection

Lab analysis support

Education

Associate Degree in Science

High School Diploma or GED

Tools

Inspection tools

Microsoft Office

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-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