Quality Assurance Specialist

4 weeks ago


Durham, North Carolina, United States DivIHN Integration Inc Full time

At DivIHN Integration Inc, we are seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing in-process and final inspections using various gauges, tools, and inspection techniques.

Key Responsibilities:

  • Accept or reject products according to inspection criteria.
  • Report issues to supervisor and record findings on inspection documents.

This role requires:

  • Ensuring that process and quality inspections are recorded in correct designated forms based on product manufactured.
  • Procuring inspection samples from in-process or finished products as stated on the inspection documentation.
  • Inspecting labels, lot numbers, count, and packaging configuration for compliance to specifications.
  • Rejecting defective product and notifying manufacturing supervisor and quality technician.
  • Writing a Non-Conformance Material Report (NCMR), coordinating with Operation to pull suspected product off skid/pallet and ensuring it properly located it to rework or quarantine area.
  • Responsible for identifying each skid/pallet of questionable product.
  • When rework is complete, re-auditing for acceptability.
  • Writing information about each product in a daily log to be used as a reference for inspectors on other shifts.
  • Answering operator questions and troubleshooting issues with supervisor and technicians.
  • May be asked to help with the inspection and testing of validation samples, raw materials and/or incoming inspections.
  • Maintaining a clean and safe work area.
  • Following GMP and ISO regulations and company policies and procedures.
  • Ensuring adherence to plant quality standards.

Working Conditions:

  • Exposure to industrial machinery, moving parts, electrical and other energy sources.
  • Personal Protective Equipment (PPE) required including but not limited to lab coats, hair/beard covers, gloves, ear protection, eye protection and head coverings.
  • Exposure to fumes and chemicals such as cleaners, inks, and solvents.
  • Exposure to high frequency noise.
  • Frequently lifts and/or moves up to 25 pounds and up to 65 pounds occasionally.

Requirements:

  • HS Diploma or GED required.
  • 1 year experience within a manufacturing environment.

Preferred:

  • At least 1 year experience performing quality inspections or serving in a quality control role.
  • Must be capable of working in a team environment.
  • Must be able to read and understand standard operating procedures, and other manufacturing work instructions and forms.
  • Must be able to perform simple math calculations, e.g. addition and subtraction.
  • Participation in regular on-the-job training regarding product, cGMP/Quality, equipment, processes, performance, and any changes that impact daily production.

About us:

DivIHN Integration Inc is an equal opportunity employer. We do not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.



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