QA Technician

Employment Type

: Full-Time

Industry

: Miscellaneous



Medina, New York, 14103

ESSENTIAL FUNCTIONS:
  • Perform inspection and test procedures for final device acceptance and release.
  • Channels accepted or rejected products to the appropriate locations.
  • Performs the various procedures needed to ensure quality products.
  • Accurately record all observations and report any non-conformances.
  • Complete the approval and closure process for any non-conformances with the device.
  • Perform quality data entry and reporting as required.
  • Ensure process control and maintenance procedures are being followed.
  • Recognize out of compliance/out of tolerance situations and take appropriate action.
  • Perform other duties as assigned.
  • QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:
  • Knowledge and working application of the following: Measurement equipment.
  • Knowledge of basic ESD requirements
  • Data entry and spreadsheet applications.
  • Ability to: stand or walk for long periods, lift and carry at least 20 pounds
  • Perform repetitive motions with hands/fingers.
  • Knowledge of cGMP documentation and FDA required.
  • Demonstrated attention to details and accuracy, required.
  • Must have good communication skills.
  • May be required to work flexible hours and overtime on short notice.
  • EDUCATION/EXPERIENCE REQUIRED:
  • Bachelors’ degree with 0-2 years related experience or Associates with 1-3 years-related experience or High School diploma with 2-4 years experience.
  • Experience in a pharmaceutical or Biotech industry helpful.
  • Must be familiar with cGMP and FDA requirements.
  • Knowledge of aseptic techniques may be required.
  • PHYSICAL DEMANDS: ?
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee:
  • Must be able to sit for most of the work day.
  • Must have good hand to eye coordination and dexterity
  • WORK ENVIRONMENT:
  • Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture.
  • Some of those work rules include but are not limited to:
  • Wearing a static protective smock at all times while in the work area
  • Wearing a ground wrist strap and plugging that wrist strap into the working table if at an ESD sensitive station.
  • Working in close proximity to other employees.
  • Working in an environment that is temperature and humidity controlled.

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