Manager of Vaccine Quality Control Laboratory
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.
Manage teams responsible for Quality Control testing in a Biologics Laboratory.
Solve complex problems and acts as a resource for colleagues across multiple areas.
Establish and maintain QC testing for biological and pharmaceutical to assure all product requirements are met. Manage a formal testing program to ensure that product is maintained and meets USDA regulations.
Lead teams or large projects and apply business skills related to building working relationships, forecasting, planning and cost control.
Instill and maintain robust safety and quality culture
Oversees and assists with USDA submissions, especially Form 2008
Collaborate with other teams to ensure both internal and external customer needs are met
Works closely with site management from multiple functions such as Operations and R&D in coordination of new product introductions and related testing
Use Lean Manufacturing tools for effective problem solving and continuous improvements
Proactively elevate any issues impacting safety, quality, or delivery goals
Perform in-depth investigations and write and maintain CAPA's (Corrective Action Preventative Action)
Fill in for the Quality Director as needed to ensure Midwest region is performing and related projects are on track.
Monitor area's performance metrics, making adjustments as necessary to ensure compliance
Ensure area personnel are properly trained on SOPs, Compliance, procedures, etc.
Complete annual performance/compensation process for direct reports; Aid staff in goal setting and identifying annual development plans.
Education Minimum Requirement:
Bachelor of Science Degree in a scientific discipline or equivelent.
Required Experience and Skills:
Thorough knowledge of testing requirements and regulations as stated in 9CFR.
Proven experience using Lean Manufactoring tools for problem solving and process improvements.
Preferred Experience and Skills:
Five + years previous experience in Quality Control in animal vaccine industry
Five years in a supervisory/management capacity.
Master level degree in a Science/Business field. Knowledge of animal husbandry, chemistry, bacteriology and virology desired. Expertise in SAP and Quality Assurance Systems. Animal vaccine EU/GMP experience. Ability to handle multiple priorities.
Animal Vaccine USDA 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.
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Job: Quality Lab Related
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck