Manager, Quality Control

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

The Quality Control Manager provides quality oversight of the qualified utilities and facility environmental monitoring sampling at the West Point vaccine manufacturing site.  The Manager, with guidance from the Associate Director of Environmental Monitoring, ensures the qualified utilities (Water-for-Injection, Clean Steam, Compressed Gases) and Facility EM (Surface, Air, and Personnel Sampling), are being sampled as required and are operating in a state of environmental control.  The Manager is responsible for the scheduling, review, and evaluation of testing data from qualified utilities and environmental monitoring.  This position works closely with the vaccine manufacturing departments to ensure timely completion of tasks with emphasis on right first time. 

The Manager will become knowledgeable in regulatory agency requirements and cGMPs to assure the qualified utilities and facility monitoring operate in a state of compliance and will train on and gain competency in their responsibilities. 

Primary Responsibilities

• Manage technicians performing sampling

• Collaborates with shop steward and team lead to schedule testing and ensure timely and compliant sampling

• Monitor testing performance against specifications

• Provide support to manufacturing and laboratories as needed

• Actively participates in meetings and escalates concerns and best practices

• Collaborates with EM utility team and vaccine manufacturing in the identification and implementation of continuous improvement initiatives and action plans

• Adherence to SOPs, GMPs, and safety procedures

• Develop and manage SOP's, departmental project protocols and reports

• Lead or contribute to key laboratory operations projects focused on compliance, capacity, demand management, assay performance, process improvement, and alignment with corporate goals.

Education Minimum Requirement

• Bachelor's degree in biology, Engineering, Chemistry preferred, equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting

Required Experience and Skills 

• At least three (3) years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological/Analytical Laboratory Operations

• Evidence of good verbal and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills

• Attention to detail, flexibility, and an awareness of production and associated quality control problems

• Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical, or related fields

Preferred Experience and Skills

• Managing/supervising teams

• Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment

• Effective problem-solving skills

• Ability to manage multiple projects/tasks simultaneously

Required Skills:

Analytical Method Transfer, Analytical Testing, Analytical Thinking, cGMP Compliance, cGMP Regulations, Corrective Action Management, Deviation Management, Driving Continuous Improvement, Good Manufacturing Practices (GMP), Instrumentation, Laboratory Information Management System (LIMS), People Management, Pharmaceutical Quality Control (QC), Quality Control (QC), Quality Standards, Technical Writing

Preferred Skills:

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