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Specialist Quality Assurance

Aditi Consulting West Greenwich, RI

  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Title: Specialist Quality Assurance

Location: West Greenwich, RI

Duration: 12+ Months Contract (Potential to extend)

 

Description:
**On-site in Rhode Island**
Minimum 2 years of experience, this employee will be expected to ramp up quickly and work independently.

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. Clients 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 regarding 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.

 

3 must have skills:

Raw Material
Quality Oversight
Deviations

Company Description
We are a technology solutions company helping organizations accelerate their business innovation and growth through project and talent solutions.

Aditi Consulting

Why Work Here?
We are a technology solutions company helping organizations accelerate their business innovation and growth through talent solutions.

We are a technology solutions company helping organizations accelerate their business innovation and growth through project and talent solutions.

Aditi Consulting's Logo

Address

West Greenwich, RI
02817 USA

Industry

Technology

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