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Quality Assurance Senior Associate

West Greenwich, RI 02817

Posted: 09/23/2024 Employment Type: Contract Job Category: Quality Job Number: 3993

Job Description

In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.

Responsibilities:
  • Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
  • Ensure that deviations from established procedures are documented per procedures.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alert management of quality, compliance, supply and safety risks.
  • Complete required assigned training to permit execution of required tasks.
  • Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
  • Communicating and collaborating with the PQA shift to ensure required tasks are completed
Basic Qualifications    
  • High school/GED + 4 years and / OR work experience OR Associate + 2 years work experience OR Bachelor + 6 months work experience
Preferred Qualifications:
  • Bachelor’s Degree & 4 year of Quality/Manufacturing experience
  • cGMP Experience
  • Excellent written and verbal communication skills
  • Experience with decision making
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About West Greenwich, RI

Ready to embark on your next career adventure? Explore our job opportunities in the vibrant area surrounding West Greenwich, Rhode Island! Nestled in the heart of New England, this charming region offers a perfect blend of historic charm and modern opportunities. From the picturesque coastline of Narragansett Bay to the lively arts scene in Providence, the Ocean State is teeming with potential for growth and success. Immerse yourself in the rich culture, savor the local delicacies like clam cakes and chowder, catch a show at the Providence Performing Arts Center, or cheer on the Pawtucket Red Sox at McCoy Stadium. Discover why West Greenwich, RI, is not just a place to work, but a place to thrive. Explore our job listings today and take the first step towards a fulfilling career in this unique and enchanting region.