Requisition ID: QUA008255
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.
The Cross-Contamination SME will be accountable for the Cross-Contamination programs at the Elkton, VA. Manufacturing site. The incumbent will be part of a site-wide compliance team and be the subject matter expert on cross-contamination. The role will require working closely with Quality, Technical, Production, Regulatory Agencies, Vendors and IT organizations at the local and global level.
Specific duties include:
- Works in an empowered, self- directed culture with a great deal of independent decision making, planning and coordination to ensure the site remains compliant.
- Subject matter expert in Cross-Contamination across the Elkton Site.
- Develops and maintains a comprehensive cross contamination strategy for the site
- Interfaces with regulatory agencies
- Develops and maintains site procedures
- Reviews updates to handbook and divisional guidelines
- Analyzes and solves problems using standard problem solving processes
- Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
- Understands the fundamental business drivers for the company; uses this knowledge in own work
- Understands and applies regulatory / compliance requirements relative to their role
- Reviews and approves SOPs as appropriate.
- Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate
- Other duties as requested by Quality management.
- This role requires interactions with personnel at all levels across multiple functional areas to ensure timely completion of Quality Compliance responsibilities.
Education Minimum Requirement:
- Bachelor's Degree in science, engineering, or related areas of study.
Required Experience and Skills:
- Minimum of five (5) years experience in the a cGMP manufacturing environment that includes quality assurance, quality operations, or engineering
- Direct experience with Cross-Contamination program
- Ability to interact directly with regulatory agencies
- Proficiency in the use of Microsoft Office Suite.
- Support investigations
- Troubleshooting skills
- Capability to influence others and drive change.
Preferred Experience and Skills:
- 7 years experience in cGMP manufacturing environment that includes quality assurance, quality operations, or engineering
- Ability to multi-task and manage/prioritize multiple projects and deadlines
- Strong analytical and problem solving skills
- Six Sigma Green Belt Certified
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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Visa sponsorship is not available for this position.
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Job: Quality Operations
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia