QA Senior Specialist

MSD • Millsboro, DE

3d • Hybrid

About The Position

The Senior Quality Specialist is a key leader in ensuring site-wide compliance with cGMPs and regulatory requirements through robust quality systems and proactive auditing activities. This role provides quality oversight for manufacturing operations, with primary responsibility for managing and executing critical quality systems (e.g., change control, deviation management, and document control), conducting GMP walkthroughs, and supporting internal and external inspections. The Senior Quality Specialist performs detailed review and approval of batch records, SOPs, and quality documentation to ensure accuracy, completeness, and Right First Time (RFT) execution. Working in a team-based environment, the position partners closely with Operations and other functions to identify and implement continuous improvement initiatives, support significant investigations, and participate in validation and process simulation activities to maintain a strong state of compliance for all products manufactured.

Requirements

• Minimum Requirement Associate degree with five years working in laboratory, manufacturing, or quality position
• Bachelor's degree in Veterinarian, Biology or other related scientific areas of study, with at least three years working in laboratory, manufacturing, or quality position
• Familiarity with GMP documentation review is a key skill necessary for success in this position
• Evidence of leadership skills coupled with good oral and written communication skills
• Understanding of cGMPs and of regulatory requirements as they apply to the biologics field or a related area

Nice To Haves

• Understanding of regulatory requirements as they apply to the biologics field or a related area
• Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas
• USDA Required Skills: GMP Compliance, Manufacturing, Manufacturing Operations, Quality Compliance, Quality Standards, Quality Systems Compliance, Regulatory Compliance, Risk Management

Responsibilities

• Provides direct support for IPT / COE as assigned.
• Performs Quality review, approval, and submission of finished product serials
• Performs Quality review and approval of new and updated SOPs, QCPs, and other Controlled Documents.
• Aids all areas of the site in drafting and review of significant investigations as needed
• Assists in the management and execution of critical quality systems such as change control, document management, Deviation management, etc.
• Performs GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements
• Assistance with external audits may also be required
• Participates in Validation activities/Process Media Simulations (Protocol Development, Approval, and Reviewer)
• Periodically facilitates Gap Assessments on our company's Animal Health Quality Manual
• Partners with Quality and Operations in the identification and implementation of continuous improvement initiatives and action plans
• Actively participates in the Tier process and uses this forum to escalate concerns and best practices

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level