Quality Assurance Specialist

1 week ago

Lakewood New Jersey, United States Renaissance Lakewood LLC Full time
Job Summary

Renaissance Lakewood LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our production team, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities
  • Perform quality assurance tasks, including production line clearances, sampling, inspections, and quality attributes testing.
  • Guide the production team on quality control measures to improve product excellence.
  • Set up and perform destructive and nondestructive tests on materials, parts, or products to measure performance or material characteristics.
  • Help develop, modify, apply, and maintain quality standards and evaluation methods for products and processes.
  • Qualify on visual inspection of in-process materials.
  • Perform routine line clearances and in-process inspections in manufacturing.
  • Provide oversight of activities on the filling and packaging areas; working with operations personnel to achieve and maintain compliance.
  • Monitor manufacturing areas during operations to ensure that batch documentation requirements and SOPs are being followed.
  • Review all documentation related to the manufacturing processes for accuracy and compliance, both online and upon completion of the activity.
  • Ability to gown to Grade A standards and perform quality inspection inside cleanroom areas.
  • Assist with investigations related to non-conformances within manufacturing or during storage.
  • Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/resamples to laboratory in a timely fashion to meet production needs.
  • Inspect and approve packaging components, manufacturing/packaging rooms, lines, and equipment prior to use.
  • Sample in-process items and finished products. Perform required inspections and testing of in-process items and finished products.
  • Apply disposition stickers to components, in-process materials, and finished products.
  • Responsible for control of label and inserts during manufacturing activities as well as issuing reports and verifying materials against associated staging sheet.
  • Responsible for reconciling unused labels and inserts and their destruction.
  • Process and distribute samples to other teams (e.g., Quality Control Laboratory) for evaluation and testing.
Requirements
  • Associates Degree required. Bachelor's Degree preferred. Science or engineering degrees preferred.
  • Previous pharmaceutical experience a plus.
  • Ability to work with computer-based systems and equipment.
  • Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
Working Conditions

The Quality Assurance Specialist will work in a fast-paced manufacturing environment with a focus on quality and compliance. The ideal candidate will be able to work independently and as part of a team to achieve company goals.

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