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Specialist Quality Assurance - (JP9384)

West Greenwich, RI · Biotech/Pharmaceutical
Job Title:  Specialist Quality Assurance - (JP9384)
Location: West Greenwich, RI. 02817
Employment Type:  Contract
Business Unit: Disposition and Validation
Duration: 6+ months (with likely extensions and/or conversion to permanent)
Posting Date: 10/29/2021

3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
minimum 2 years of experience, this employee will be expected to ramp up quickly and work independently.

The Raw Material Disposition Specialist 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 Specialist 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. client’s Raw Material Disposition provides coaching, guidance and direction to Supply Chain, Warehouse, Procurement and our PQA Partners overseeing Manufacturing Operations. As a Specialist 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.

Why is the Position Open?
Planned proejct/increasing work load.

Top Must Have Skills:
  • Raw Material.
  • Quality Oversight.
  • Deviations.

Day to Day Responsibilities:
  • Deviation QA closure.
  • Raw Material Disposition of Chemicals and Components.
  • Quality Oversight of the Warehouse and Operations.

Employee Value Proposition:
The opportunity to work alongside seasoned industry professionals as well as gain valuable work experience.

Red Flags:
  • No quality experience.
  • No raw material experience.

Interview process:
Video Skype Panel Interview

We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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