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Merck
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Durham, North Carolina
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incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal ... enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished
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Merck
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Durham, North Carolina
...
incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal ... enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished
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Merck
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Wilson, North Carolina
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successful implementation of changes and/or process improvements.
Leading and implementing changes while ... , change controls, incidents, CAPA’s, etc.
Communicating effectively while being open and approachable
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Merck
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Wilson, North Carolina
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as the business unit manager for the cross-functional integrated process team (IPT) supporting the ... providing tactical and strategic direction to the Vaccines IPT. This includes ensuring that business
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Merck
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Durham, North Carolina
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for supporting:**
Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography ... complete routine calibration tasks, work with and troubleshoot complex process systems Contributes to the
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Merck
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Durham, North Carolina
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for supporting:**
Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography ... )
Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems
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Merck
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Durham, North Carolina
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regulatory filings
Support Change Control documentation for complex process, validation, analytical ... required at times based on business unit needs and specific assignments.
Specific assignments may be
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Merck
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Durham, North Carolina
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. Off-shift and weekend coverage will be required at times based on business unit needs and specific ... projects goals and deliverables related to the vaccine process.
Lead validation studies and author the
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Merck
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Durham, North Carolina
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aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The ... -documented, while meeting timing commitments
Lead in the identification and implementation of process
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Merck
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Raleigh, North Carolina
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veterinarian who is technically proficient, has a high level of business acumen, has experience partnering with ... strategic account plans to maximize business opportunities and drive revenue growth within assigned
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Merck
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Durham, North Carolina
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aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior ... implementation of process improvement projects, productivity initiatives and corrective actions while focusing on
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Merck
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Durham, North Carolina
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. Maintains, cleans and prepares equipment used in production.
Performs sampling/in-process testing supporting the manufacturing and validation process for current process.
Provides timely delivery of
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Merck
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Durham, North Carolina
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activities that support cGMP and regulatory compliance during microbiological method transfer/qualification ... , method transfer/qualification reports, standard operating procedures, change controls, and investigations
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Merck
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Durham, North Carolina
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Purification manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Tangential Flow Filtration, Chromatography, Homogenization, Process Monitoring
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Merck
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Durham, North Carolina
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safety, and regulatory requirements as written
Works in a team environment to accomplish ... to business operations, in which case you may not be offered employment, or your employment could be
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Merck
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Durham, North Carolina
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of technology transfer process knowledge, post approval support, and post commercial process ... downstream purification process for the technology transfer of our Company's HPV vaccine drug substance
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Merck
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Durham, North Carolina
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, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business ... laboratory areas, KPI reporting and facilitating regulatory audits. The individual in this role will provide
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Merck
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Durham, North Carolina
...
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Provide support to all Quality related audits from external and regulatory agencies .
Participate in Quality Risk Assessments and serve as QA SME
Review and approve validation reports
Identify
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Merck
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Durham, North Carolina
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. Ensure regulatory compliance.
GENERAL PROFILE:
Coordinate the collection and ... delivery of reconditioned drums with external services and production.
**BUSINESS EXPERTISE
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Merck
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Wilson, North Carolina
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, packaging process and controls and packaging operation.
Under general scientific and administrative ... of potential risk to business success and generate gap analysis.
Significant experience with
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Merck
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Durham, North Carolina
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, packaging process and controls and packaging operation.
Under general scientific and administrative ... of potential risk to business success and generate gap analysis.
Significant experience with
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Merck
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Raleigh, North Carolina
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role in supporting our customer centric business model.
This position is responsible for ... business. Responsibilities include providing technical support for Ruminant products and programs
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Merck
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Raleigh, North Carolina
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discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an ... with ability to understand how MIDD can drive portfolio and regulatory decisions
Deep knowledge of
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Merck
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Raleigh, North Carolina
...
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Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports
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Merck
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Raleigh, North Carolina
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understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial
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