QC Inspector I

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

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 Qualification

• 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
• shift hours: 1:00 PM- 9:30 PM, flexible to work Overtime. 

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