Requisition ID: QUA007933
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.
Position carries out a variety of activities to support production of a bioburden reduced vaccine intermediate product. The position must become familiar with site processes, procedures, and policies assuring alignment with cGMPs (current Good Manufacturing Processes) and Health Authority regulations. Conducts batch record reviews, audits, investigations, and helps with internal audits / external inspections. Performs quarantine functions and accountability reviews. Reviews and approves SOPs for production, cleaning, mainenance and utility support activities. Supports special projects as assigned. Follow cGMP and routinely makes decisions using cGMP/process knowledge. Works with customers to resolve problems and to satisfy quality and production needs. Performs regulatory document reviews and prepare regulatory or other required documents per local and divisional guidance. Follows site safety requirements. Authors, reviews, and or approves data and documents such as methods, procedures, and protocols. Completes assigned projects. Performs all work in a timely manner and is an active member of 1 or more teams. Tracks/reports metrics.
Education Minimum Requirement:
- Bachelor's degree Scientific (biology, engineering, physics, psychology, engineering, other)
Required Experience and Skills:
- 2 years experience in pharmaceutical industry or quality assurance/control
- Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues. Interpretation of vague guidance for application in specific control systems and equipment
- Demonstrated verbal/written communication and decision making skills
- Experience with GMP/compliance requirements for food or pharmaceutical industry; technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding; sterile/aseptic processing experience
- Act with Courage and Candor - demonstrated ability and willingness to advocate for compliance position using objective evidence
- Collaboration - ability to maintain productive communication channels with stakeholders
- Utilize several laboratory data, inventory, quality management, maintenance, and other computerized systems.
- Learning agility - demonstrated ability to continually learn new technical, quality/compliance, & regulation knowledge and apply
Preferred Experience and Skills:
- Demonstrated independent thinking
- Knowledge of and experience in Quality Risk Management methods
- Ability to prioritize and balance work from multiple projects in parallel
- Working knowledge of manufacturing and utility systems, controls, and processes
- Experience with mechanical, electrical, and P&ID drawings
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: Qual Assurance & Ops Generic
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