Merck is a leading pharmaceutical company, and they are seeking a Laboratory Operations Quality Specialist- AVS to provide quality oversight of Airflow Visualization Studies. The role involves ensuring studies are performed according to schedule and acceptance criteria while collaborating with various departments to support timely task completion.
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
Skills
- 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
- 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
- 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
- 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
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
Company Overview
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