Manager, Quality Control

MSD • Elkhorn, NE

4d • Hybrid

About The Position

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality 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 Control (QC) Manager is accountable for oversight of activities performed in the QC laboratories to ensure timely release of high quality, compliant products to market. The QC Manager is responsible for ensuring that the testing and results obtained in QC comply with internal and external regulatory guidelines. Personnel tasks involve daily contact with the technicians under his/her direct supervision, including acting as a technical advisor and “coach”. The QC Manager serves as a technical and administrative resource for other department personnel. Additionally, the QC manager will utilize Lean/Six Sigma knowledge to make efficiency improvements in his/her department.

Requirements

• Bachelors of Science degree in Microbiology, Biology, Biochemistry, Chemistry or a related field.
• Knowledge of testing procedures and systems used in a QC laboratory.
• Knowledgeable in USDA testing procedures, supplemental assay methods and 9 CFR regulations.
• Three to five years supervisory experience within the biologics industry.
• Experience with GMP documentation practices
• Individual must be highly organized and possess good planning skills to handle multiple projects.
• Individual must have good communication skills and ability to interface with all levels of the organization.
• Good technical writing experience
• Excellent computer skills (i.e. Word, Excel, Power Point, Microsoft Office, etc.)

Nice To Haves

• Strong knowledge of USDA, GMP, FDA or EMEA regulation regarding vaccine manufacture
• Assay validation methods and report writing.
• Experience with lean, six sigma or similar

Responsibilities

• Advocate “Safety First, Quality Always” mindset by perform periodic Gemba walks in the laboratory and in other departments.
• The Quality Control Manager is accountable for managing the Quality Control and testing processes that support the facility, while actively supporting and participating in a team culture.
• Coordinate laboratory activities with the technicians.
• Ensure tests are performed within internal and external regulatory requirements and within established lead times.
• Review testing results and data and be able to identify abnormal events for escalation.
• Coordinate the preparation of QC metrics reports needed for management meetings and discuss results at department or inter-department meetings.
• Be actively involved in the hiring and training of technicians.
• Act as a mentor/coach for the technicians directly reporting to this position.
• Encourage development of direct reports to set and achieve objectives.
• Write and perform the performance evaluations of direct reports.
• Handle interpersonal conflicts.
• Provide leadership for the investigation of testing issues that may arise within QC.
• Actively participate as needed and consult with other staff on related issues and special projects involving QC testing issues and methods.
• Actively participate in the development and transfer of testing methods from Research & Development or other departments to QC.
• Write and revise test methods, SOP’s, Outlines of Production, Special Outlines, test records, and forms and ensure that all documents used in QC comply with internal and external regulatory requirements.
• Write and review technical reports for submission to USDA or other health authorities.
• Assist the QC management/Site Quality Head in the preparation of the annual budget.
• Prepare documentation for budgeted capital equipment and supplies
• Participate in other special projects or activities as assigned by management.
• Other duties may include Strategic Planning intended to develop and execute departmental plans and priorities based on site, regional or company driven goals.
• Support of regulatory inspections and audits.
• Support of validation activities and other associated Quality functions.

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: Manager
• Number of Employees: 5,001-10,000 employees