QC Inspector I- 3rdShift

Job Overview

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

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.
• Checks that the assembly or production line adheres to standards and procedures.
• Assists with the initiation of QMS documents like Non-conformance Investigations.
• Complies with all quality, safety, and work rules and regulations.
• Must be flexible to work a variety of schedules to meet business needs.
• Performs other related duties as assigned.

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 refrigerators 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.

What 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.