Specialist, Quality Assurance (Second Shift)

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our quality standards and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Specialist provides Quality support to laboratory and/or manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operations of pharmaceutical, biologic, and/or vaccine manufacturing facilities. The successful candidate must be able to examine issues from diverse perspectives, provide a hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.

• →Minimum four (4) years of experience in manufacturing, maintenance, laboratory, military environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry.
• →Schedule: Monday - Friday, 2:00 PM - 10:30 PM EST (will include weekends and holidays to support ongoing manufacturing activities). 

• At least 1 year of experience in aseptic manufacturing or other clean room environment.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills.  Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
• GMP quality experience with biological drug substance or drug product.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat, SAP, Veeva and/or GLIMS.
• Experience in deviation management with focus on quality review and approval.
• Experience in Aseptic processing, aseptic observations, and techniques.
• Electronic manufacturing batch records (eMBR) experience.
• Demonstrated interpersonal skills including flexibility and collaboration.
• Demonstrated analytical aptitude, critical thinking skills, and problem solving.
• Demonstrated ability to upskill others.
• Demonstrated verbal and written communication skills.
• Experience in pharmaceutical related environment.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.