Quality Specialist - AVS

MSD

23h • Hybrid

About The Position

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

Requirements

• 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 to the vaccine, sterile pharmaceutical, or related fields.

Nice To Haves

• 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

Responsibilities

• Scheduling of Airflow Visualization Studies
• Written documentation for Airflow Visualization Studies
• Video recording of Airflow Visualization Studies
• Video editing of Airflow Visualization Studies
• Aseptic Gowning
• Working relationship with IPTs
• Video editing and storing of video evidence per data integrity requirements
• Recording video in Grade A areas
• Manage 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

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