In-Process Quality Assurance Technician

VVF IntervestMontgomery, IL
Onsite

About The Position

The In-Process Quality Assurance Technician (IPQAT) is responsible for performing the real-time quality checks and for coordinating different quality activities on the shop floor during the various stages of manufacturing process (end-to-end manufacturing lifecycle – from raw/pack materials to finished products). This role ensures that all products are manufactured and documented in compliance with cGMP regulations, customer requirements and internal SOPs.

Requirements

  • Bachelor's Degree, preferably in Science
  • Ability to work independently and as part of a team
  • Strong attention to detail, ability to detect aesthetic defects, planning and organizational skills
  • Strong written, verbal and interpersonal skills
  • Provide Quality oversight

Nice To Haves

  • 2+ Years of Operations/Quality experience in a cGMP regulated facility within manufacturing
  • Proficiency in database management, Microsoft Office, or equivalent computer systems

Responsibilities

  • Conduct regular inspection/checks of in-process and finished products using established procedures to ensure conformance with specifications and standards.
  • Monitor and verify the critical control points, line clearance and cleanliness prior to batch production to ensure the production line area is free of any product, components and documentation of the previous product.
  • Conduct regular review of Batch Manufacturing Records and associated forms for accuracy and completeness, and according to good documentation practices.
  • Verify the Batch History Record changeover forms are completed properly and accurately.
  • Verify calibration status of equipment and instruments used in manufacturing.
  • Collect & label samples according to the established sampling plan for laboratory testing and inspection.
  • Ensure adherence to cGMP requirements and good documentation practices on the shop floor.
  • Enforce Controlled documents usage on the shop floor.
  • Issue nonconformance reports for quality related issues on the shop floor.
  • Escalate quality issues immediately to immediate supervisor and Quality Head
  • Responsible for placing quality holds or rejected status on the non-conforming products and its proper segregation to avoid mix-up with good products.
  • Participate in the root-cause investigations and support CAPA implementation on the shop floor.
  • Oversee any product rework due to quality issues and ensure proper documentation as per the rework instructions.
  • Inspect the reworked products to confirm corrected products meet customer requirements.
  • Complete other tasks assigned by your supervisor.

Benefits

  • medical, dental and vision insurance available on day 1 of employment
  • Life Insurance, Short-Term and Long-Term Disability coverages are provided and paid for by the company
  • company match on employee contributions into our available 401(k) retirement plan
  • company paid holidays and vacation time
  • business casual work environment
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