Senior Specialist, MDCP Quality
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Reporting to the Director MDCP Quality Systems and Compliance, lead responsibilities include:
- Manage activities within electronic computer systems, e.g. AMS Blue, MIDAS, RCAM, TrackWise, SAP, Success Factors (LMS), etc.
- Assist with system support and record management.
- Maintain document and data integrity in electronic computer systems.
- Plan and coordinate MDCP Quality meetings (i.e.; Change Control, CAPA, Deviation Management, etc.) and manage meeting minutes, records and documents.
- Collect, graph and analyze data for quality metrics.
- Oversee MDCP mailbox and manage timely responses
- Manage MDCP projects for Quality System Improvement Program (QSIP) activities.
- Collaborate with teams across cultures at all levels and foster continuous improvements
- Write standard operating procedures and create forms and templates.
- Manage documents in the electronic computer systems throughout their life cycle.
- Create training materials for documents and manage MDCP Quality curricula.
- Participate in SAP Data Governance Community of Practice as MDCP Quality Data Steward.
- Support local MDCP sites with new/revised SAP Material Masters with MDCP identifiers.
- B.S. and/or M.S. degree in an appropriate Science or Engineering discipline
- Minimum of six (6) years’ experience with pharmaceuticals/medical devices/combination products
- Effective interpersonal skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others
- Effective written and oral communicator
- Able to speak up and contribute in a team forum
- Able to apply prior experiences and learning in new settings, even if these are unfamiliar
- BS in an appropriate Science, Engineering or Business discipline
- Proven working experience in project management
- Proven experience with electronic quality systems, e.g. document management, training, deviation management, CAPA, change management.
- Proven experience authoring documents
- Excellent client-facing and internal communication skills
- Excellent written and verbal communication skills with experience presenting information at meetings
- Solid organizational skills including attention to detail and multi-tasking skills
- Strong working knowledge of Microsoft Office suite of software
- Working knowledge of technical aspects of device development and commercialization
- Development, product approval, and/or inspection experience with the medical device constituent of a combination product is an asset
- Development and delivery of training is an asset.
- Preferred working knowledge of pharmaceutical and/or medical device manufacturing and quality operations
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck