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Quality Assurance Manager

West Greenwich, RI
Top 3 Must Have Skill Sets:    

Ideal candidate – 5+ years industry experience. CGMP Manufacturing, Pharma, or Bio pharm industry is preferred.
Quality oversight experience (3-5 years)
Preferred -including, equipment and computer validation.
Applied experience in Technical Writing experience-able to review protocol and understand if something isn't worded correctly.

Description:

This resource will be required to sit on-site at Rhode Island.
Ideal candidate – 5+ years industry experience. CGMP Manufacturing, Pharma, or Bio pharm industry is preferred.
Quality oversight experience (3-5 years)
Including, equipment and computer validation.
Applied experience in Technical Writing experience-able to review protocol and understand if something isn't worded correctly.



Responsibilities:
Quality oversight of activities for facilities, utilities, equipment, systems and process with alignment and integration into the Quality Systems, including:
• Review/approve operation support such as: standard operating procedures, user requirements, risk assessments, training materials, automation documents,
• Review and Approval Qualification/validation protocols/reports, environmental qualification protocols/reports,
• Provide on-going Quality oversight for execution of activities. to ensure operations occur, according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
o Ensure facilities, equipment, materials, organization, processes and procedures comply with cGMP practices and other applicable regulations.
• Complete required assigned training for self, and ensure training of staff, to permit execution of required tasks. Perform training activities, as needed in support of Quality Assurance program
• Manages and oversees the operations of a specific area(s) of responsibility

Admin shift with flexibility to support off shifts as needed

Ideal candidate – 5+ years industry experience.
Experience in Qualification/Validation including process, equipment and computer validation. Applied experience in Technical Writing and Quality oversight

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

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