• The Laboratory Operations Quality Specialist- AVS provides quality oversight of the Airflow Visualization Studies at the West Point vaccine manufacturing site
• The Specialist, with guidance from the Associate Director of Environmental Monitoring Site Support, ensures AVS are performed per the required schedule; meeting the necessary acceptance criteria
• The individual will be responsible for scheduling, written documentation, video recording, and video editing of the studies
• This position works closely with the vaccine manufacturing departments and Engineering/Maintenance to ensure timely completion of tasks with emphasis on right first time
• The specialist will become knowledgeable in regulatory requirements and cGMPs to assure the AVS are executed according to requirements and gain competency in their responsibilities
• Aseptic Gowning
• Working relationship with IPTs
• Strong understanding of aseptic technique and first air principles
• Video editing and storing of video evidence per data integrity requirements
• Recording video in Grade A areas
• General knowledge of computers and technology
• Mange SOP updates
• Author protocol and reports, memos, and annual evaluations
• Provide support to manufacturing and laboratories as needed
• Identify and implement continuous improvement initiatives and action plans
• Adherence to SOPs, GMPs, and safety procedures
• Note: In this position the individual will be required to move large Dewars (>50 pounds) of N2, hold a video camera or fogger apparatus for long periods of time

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Bachelor's degree required
• Evidence of good oral 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 problems
• Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical, or related fields

Valid Driving License

Adaptability, Adaptability, Aseptic Manufacturing, Aseptics, cGMP Compliance, Computer Information, Computer Technology, Continual Improvement Process, Data Analysis, Decision Making, Documentation Review, Documentations, Environmental Monitoring, Environmental Monitoring Systems, FDA Regulations, GMP Compliance, Immunochemistry, Interpersonal Relationships, IS Audit, Laboratory Operations, Laboratory Quality Control, Management Process, Problem Solving Therapy, Quality Inspections, Quality Operations {+ 5 more}

$85,600.00 - $134,800.00 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.Company.com/us/en/compensation-and-benefits

No relocation