Quality Specialist - AVS

Merck & Co. • West Point, PA

118d • $85,600 - $134,800 • Onsite

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.

Requirements

• Bachelor's degree required, preferably in Biology, Engineering, Chemistry or related field
• Evidence of good oral and written communication 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
• Strong problem-solving skills
• Demonstrated ability to manage multiple projects/tasks simultaneously

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
• 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

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree