Manufacturing Compliance Specialist

Company: Integrated Resources, Inc ( IRI )
Location: Norton
Posted on: May 11, 2022

Job Description:

The Manufacturing Compliance Specialist is responsible for providing GMP compliance, technical operation, and documentation support for quality systems and to meet regulatory requirements for Alnylam's Internal GMP Manufacturing facility located in Norton, MA. This position will manage deviations, CAPAs and change controls as well as create, review, and approve various manufacturing documentation, including standard operating procedures, protocols, and reports.
The Manufacturing Compliance Specialist position reports to the Sr. Manager, Manufacturing.

Summary of Key Responsibilities:
--- Develop, implement, and manage strong GMP systems for manufacturing operations with adherence to quality standards and applicable guidelines and regulations
--- Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Engineering, Validation, and Facilities to implement product, process, and raw material improvements.
--- Provide support for Norton manufacturing operations, investigations, continuous improvement projects, and program lifecycle management
--- Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems.
--- Ensures timely completion of manufacturing documentation and/or quality systems to achieve disposition requirements.
--- Support training, documentation, change controls, deviation and CAPA activities.
--- Organize and lead ad hoc cross functional teams to manage investigations and implementation of changes
--- Experienced with root cause analysis methodology/tools.
--- Ensure high levels of communication with team, support resources and management regarding issue identification and resolution.
--- Supports the generation, review, and approval of various manufacturing documentation, including procedures, protocols and reports, quality systems, and investigations. Acts as manufacturing subject matter expert for assessments for change controls, validation protocols, and document changes.
--- Provides support to Manufacturing program documentation, including training requirements and methodology, safety requirements, and cost savings initiatives.

Requirements:
--- At least 4 years' experience in a GMP Facilities environment within the biotech or pharmaceutical industries
--- Highly Knowledgeable of quality systems and cGMP regulations
--- Must have excellent interpersonal and customer service skills
--- Excellent written and oral communication skills

Keywords: Integrated Resources, Inc ( IRI ), Brockton , Manufacturing Compliance Specialist, Other , Norton, Massachusetts