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