Job title : Quality Assurance Specialist

Work Location : West Greenwich RI 02817 – Hybrid - 3 days can be remote in a week

Duration : 12 months (Possible extension)

Job Description:

• Let’s do this. Let’s change the world. The Quality Assurance (QA) Technical Services Specialist is a critical role for the ARI site. The QA Technical Services team provides quality oversight for the execution of key processes such as deviations, corrective actions, and change controls; as well as general quality partner support for functions outside of manufacturing (including PD, IS, and QC). Because the function is engaged with complex investigations and delivery of site strategic priorities, the role offers the opportunity to engage broadly across the ARI site and within the network.
• QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement initiatives, therefore, the ideal candidate will have demonstrated competencies across a broad range of quality-related disciplines.
• The role also includes Quality oversight associated with commissioning and qualification and validation activities across the site This role demands a proactive and autonomous professional, capable of making risk-based decisions to uphold and improve our quality management system.

Key Responsibilities include:

• Provide quality advice and oversight to ensure products are manufactured, tested, stored, and distributed according to current good manufacturing procedures.
• Develop and maintain a working understanding of applicable requirements and best practices.
• Leverage knowledge and experience to provide risk-based Quality advice on strategies for successful investigation of deviations; as well as implementation of corrective actions, and change control
• Perform review and approval of GMP processes, procedures, documents, and records, including deviations, corrective actions, change controls, effectiveness verifications, standard operating procedures, batch records, and protocols.
• Review/approve validation documentation, protocols, reports supporting the following qualification/validation disciplines: Equipment, Computer, Process
• Review/approve equipment and computerized systems periodic review reports, as well as environmental qualification protocol reports
• Manage the change control process, ensuring changes are thoroughly evaluated for impact to quality, and strategies for implementation follow processes and procedures.
• Collaborate with project teams to integrate quality considerations and controls into project planning and execution.
• Independently assess and prioritize quality risks across various functions and processes.
• Implement proactive measures to prevent potential issues and ensure a state of inspection readiness
• Drive continuous improvement initiatives at the site and network level to create value for the business.

Preferred Qualifications:

• Demonstrated abilities in problem solving, and experience managing deviation/change control/ CAPA
• Excellent written and verbal communication skills with cross functional teams, network, and management.
• Experience with manufacturing equipment/systems, automation, and/or computerized systems
• Experience in Qualification/Validation including process, equipment and computer validation
• Proven ability to make informed risk-based decisions to drive continuous improvement and maintain quality and compliance.
• Experience with Regulatory inspections.