Quality Specialist - AVS

Job Description

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. Specific responsibilities include but are not limited to the following:

• 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

Bachelor's degree required. Biology, Engineering, Chemistry or related field is preferred.

• 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 tothe vaccine, sterile pharmaceutical, or related fields.

• Demonstrated interpersonal skills including flexibility, collaboration, and inclusion skills and ability to work in a team environment.
• Strong problem-solving skills.
• Demonstrated ability to manage multiple projects/tasks simultaneously

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}

Current Employees apply HERE

Current Contingent Workers apply HERE

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday -…