Job Details

  • Title: Quality Assurance Senior Associate
  • Code: RCI-10483
  • Location: West Greenwich, RI 02817
  • Posted Date: 06/23/2022
  • Duration: 12 Months
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  Job Description

Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at Company. In accordance with applicable law, Company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Company, its operations, or its staff.

 

**Full time on site in Rhode Island**

 

  • Company is seeking a Quality Assurance Senior Associate to be a part of our Company Rhode Island Quality Assurance team.
  • The role will support the inspection, sampling, and testing of raw materials that are received at the Company Rhode Island site.
  • This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process.
  • This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

 Primary Responsibilities of the Role Include:

  • Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
  • Collect samples from a statistical number of containers for all chemicals to facilitate the testing of samples
  • Use RAMAN technology with TruScan and NIR equipment to identify chemicals
  • Ensure that inspection & sampling results are complete and detailed according to written procedures, specifications and cGMP requirements
  • Responsible for accurately documenting inspection, sample, and test results in Company’s systems
  • Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
  • Ability to determine the color of raw materials match required attributes
  • Support inspection readiness activities including site audits and inspections
  • Maintains project plan commitments supporting critical projects
  • Support Continual Improvement initiatives, programs and projects
  • Own controlled documents for the area including SOPs and FORMs
  • Initiate and own deviation records and CAPAs associated with events and projects in ARI’s raw material inspections, samples, and testing areas

Basic Qualifications

  • Master’s degree OR Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience

Preferred Qualifications

  • Strong understanding of cGMP regulations and GDP requirements
  • SAP, LIMs, LMES, Maximo and TrackWise experience
  • Experience with RAMAN technology
  • Experience in raw material inspections, sampling, and testing
  • Strong written and verbal communication skills

Top 3 Must Have Skill Sets:

  • Strong understanding of cGMP regulations and GDP requirements
  • Strong written and verbal communication skills
  • Experience in raw material inspections, sampling, and testing
  • Bachelor’s degree and 2 years of cGMP inspecting and/or sampling experience