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Quality Assurance Senior Associate

West Greenwich, RI
Top 3 Must Have Skill Sets:
Experience working in Biotech industry or relevant equivalency (ie. GMP facility)
Attention to details
Experience in raw material inspection, sampling or testing (or relevant experience) is ideal


seeking a Quality Assurance Senior Associate to be a part of our Rhode Island Quality Assurance team. The role will support the inspection, sampling, and testing of raw materials that are received at the 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 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
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 as a Trainer in raw material inspections, sampling, and testing

Strong written and verbal communication skills

"This posting is for Contingent Worker, not an FTE"

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