Responsibilities:
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The Process Specialist is the technical expert who is responsible for providing technical support
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Plan, prepare, issue, and control production schedule and material requirements to ensure control flow of approved material timed to meet production plan.
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Facilitate the implementation of the production plan.
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Takes corrective action for daily operational problems within the department.
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Act as subject matter expert (SME), providing guidance on deviations, investigations, and issues pertaining to quality of product.
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Study the need for improvements of existing processes, systems, and equipment, and in cooperation with related departments, undertakes optimization to increase efficiency and quality and to reduce costs.
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Recommends and implements corrective/preventative measures aimed at improving compliance and reducing repeat occurrences. Follow up to determine if corrective
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actions adequately addressed root cause of NC event.
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Provides technical support for the investigation and resolution of deviations and atypical events by partnering with Quality Assurance to ensure consistent quality standards are maintained.
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Tracks deviations, events and key process parameters and provides reports to management on trending, and status as requested. Recommends corrective actions for
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any trends identified.
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Identifies and implements process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost. Assure regulatory compliance and
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technical feasibility of proposed changes.
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Ensure department quality and safety compliance.;
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Provide documentation support for SOP/ Batch Record revisions.;
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Identify necessary document changes and ensure timely revision to all SOP and batch; records.;
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Review and approve SOP and batch record revisions.;
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Assist with equipment startup and technical training as required.;
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Provide technical support for process and cleaning validation maintenance and; verification. Assist with cleaning cycle optimization and revalidation efforts.;
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Demonstrates expertise in the following areas: cGMPs, FDA regulations, manufacturing; processes, manufacturing equipment, high purity water systems, and utilities.;
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Responsible for handling-controlled substances in compliance with applicable State and local law and requirement.;
Requirements:
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Generally, 4-6 years of work experience in a chemical, pharmaceutical, medical device, or similarly regulated manufacturing industry.
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Ability to learn and operate SAP Production, COMET, SUMMIT, to the level required.
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Technical understanding of at least one processing area.
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Ability to read, analyze and interpret procedure manuals, common scientific and technical journals, basic financial reports and legal documents, general business periodicals and government regulations.
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Ability to respond to sensitive inquiries and present information to Site Management, regulatory agencies, and members of the business community.
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Ability to define problems, collect relevant data and information, establish facts, and draw valid conclusions as required.
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Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
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Demonstrated ability to write effectively to communicate work prepared, rationalize conclusions and recommendations, and compliantly document for regulatory bodies.
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Manage and coordinate multiple project priorities as required.
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Ability to work independently on routine and non-routine tasks.
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Successfully completes regulatory and job training requirements.
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Remains current in skills and industry trends
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Experience with SAP and Minitab.
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Solid understanding of Word, Power Point, and Excel.
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Other Requirements:
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Regularly required to talk and hear, stand, walk, sit, use tactical sense, handle, or feel,
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and reach with hands and arms.
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Required to move around the manufacturing plant to perform on-site investigations.
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Needs to perform gowning procedures to work in manufacturing core.
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Specific vision abilities required by this job include close vision, distance vision, depth
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perception, and ability to adjust focus.
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Off-shift work may be required. On-call support may be required. Must be available for other duties as required.
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Travel Requirements: up to 10% domestic/international
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Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
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Technical Writing
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Nonconformance investigation documentation
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Continuous improvement projects
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Creating/Updating SOPs
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Working on Training projects and developing a clean parts management process for Operations