Smoke Study Process Steward Job
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.
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Located between Harrisonburg and Charlottesville, Virginia, the Merck facility in Elkton employs about 900 employees. The facility is a key contributor to Merck's world-wide network of manufacturing, producing vaccines, antibiotics and other important pharmaceutical products.
The Smoke Study Process Steward will be accountable for the Air Visualization program at the Elkton, VA. Manufacturing site. The incumbent will be part of a site-wide compliance team and be the subject matter expert on smoke studies. 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 in the planning, coordination, and execution of the Air Visualization program
- Subject matter expert in smoke studies
- 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.
Required Experience and Skills:
•B.S. or B.A. degree in Science, Engineering or an associates degree with 8-10 years work experience in a manufacturing environment
•Minimum of three (3) years in manufacturing environment that includes quality assurance, quality operations, or engineering
•Ability to interact directly with regulatory agencies
•Proficiency in the use of Microsoft Office Suite.
•Capability to influence others and drive change.
Preferred Experience and Skills:
•Direct experience with Air Visualization Studies
•Ability to multi-task and manage/prioritize multiple projects and deadlines
•Strong analytical and problem solving skills
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.
If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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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:
Shift (if applicable):
Company Trade Name: Merck