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Quality Assurance Senior Associate

West Greenwich, RI
Top 3 Must Have Skill Sets:
    
Quality Oversight
Attention to Detail
Preferred Raw Material Experience

The Raw Material Disposition Sr. Associate will be responsible Disposition of Raw Materials and Deviation Management. This position provides the opportunity to work directly with Supply Chain, Shipping, External Supply and Procurement for the incoming raw materials. As a Sr. Associate you will also facilitate real-time decision-making regarding quality requirements and deviations.  This is a unique opportunity to foster a strong partnership and learning environment between Supply Chain/Warehouse, External Supply and Disposition Quality staff. The primary focus of this roll will be to support the Disposition of Raw Materials and real-time decision-making regarding quality requirements and deviations. Raw Material Disposition provides coaching, guidance and direction to Supply Chain, Warehouse, Procurement and our PQA Partners overseeing Manufacturing Operations. As a Sr. Associate you would be responsible for the following in regards to compliance and quality systems:

• Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
• Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.
• Author/review/approve quality documents, such as:  SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Establish and enable LEAN practices. 
• Oversee and provide guidance of the Raw Material Reject Cage.
• Ensures that changes that could potentially impact product quality are assessed according to procedures.
• Ensures that deviations from established procedures are investigated and documented per procedures.
• Ensures that raw material batch packets and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alerts senior management of quality, compliance, supply and safety risks.
• Completes required assigned training to permit execution of required tasks.
• Drive operational improvement initiatives, programs and projects.

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

 

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