Manufacturing Compliance Specialist
Company: LanceSoft, Inc.
Location: Norton
Posted on: May 7, 2022
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Job Description:
Title: Manufacturing Compliance Specialist I
Location: Norton, MA - HYBRID - 3 days onsite per week
Duration: 06+ Months (Possible Extension)
Job Description:
Job Title: Manufacturing Compliance Specialist
Department: Internal Commercial Manufacturing Responsibilities:
The Manufacturing Compliance Specialist is responsible for
providing GMP compliance, technical operation, and documentation
support for quality systems and to meet regulatory requirements for
Company'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
Bachelor's Degree or equivalent in Engineering, Science, or
relevant filed
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: LanceSoft, Inc., Brockton , Manufacturing Compliance Specialist, Other , Norton, Massachusetts
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