Requisition ID: MAN006020
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 Production Document Expert, Associate Specialist implements improvements to production documentation and documentation processes to maintain compliance with regulatory guidelines and standard site business practices. Work is executed as an individual contributor and as part of a project team.
The following are key responsibilities within this position:
- Work closely with technical and business project teams to define the needs and support document updates and deployment for assigned process area.
- Acts as a gatekeeper for document updates within areas of responsibility.
- Manages and escalates timing issues related to documentation implementation.
- Reviews documentation for compliance with standard document content and updates documentation accordingly.
- Assist with technical support and training sessions for employees for documentation related changes and improvements.
- Coordinates updates for data integrity updates, Right-first-time (RFT) concerns, CAPAs, projects, and regulatory commitments.
- Serves as author for documents with multiple stakeholders.
- Serves as a liaision between shop floor, technical operations, and quality.
- Consults with Employee Qualification Expert for training needs and updates.
- Coordinates the needs of functional areas and establish priorities for documentation enhancements, such as implementation of new functionality, compliance with templates for new/revised documents.
- Maintains knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information.
- Participates on teams supporting internal functions and/or evaluating area procedures for improvement opportunities.
- Complete other duties as assigned by the Document Resources and Strategies Manager.
Education Minimum Requirement:
- B.S. degree in business, science, mathematics, engineering or related field
Required Experience and Skills:
- Demonstrated self-starter with capability to develop innovative solutions to challenges
- Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
- Excellent written and oral communication skills
- Experience with Microsoft Office, particularly Word and Excel
- Ability to prioritize, manage multiple tasks, and meet deadlines
- Ability to organize and maintain data or information
- Ability to learn through observation and hands on experience
Preferred Experience and Skills:
- Advanced skills with Microsoft Word
- Technical Writing Experience
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org .
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Manuf./Operations Generic
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): 1st
Company Trade Name: Merck
Nearest Major Market: Harrisonburg
Nearest Secondary Market: Virginia