Jobs

Description

Location: Frederick, MD (Onite 5 days a week)

Responsibilities:

• Provide Quality oversight and guidance for all cGMP Work Orders performed on critical equipment, facility and utilities necessary for commercial and clinical production.
• Provide Quality oversight and resolution guidance for all alarms generated by our Equipment Monitoring System (EMS) which actively monitors our critical equipment, facility, and utilities necessary for commercial and clinical production.
• Demonstrate intimate working knowledge of pharmaceutical relevant standards, principles and best practices.
• Collaborate with project teams and necessary departments (e.g. manufacturing, engineering, product development, quality control, supplier quality, supply chain) in the execution of CQV and CSV, as needed.
• Track, review and report metric information as necessary.
• Support Quality Engineering functions as necessary, including oversight of validation activities and quality risk management.
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications:

• Master’s Degree OR
• Bachelor’s Degree and 2+ years’ experience in a pharmaceutical or FDA regulated environment OR
• AA Degree and 4+ years’ experience in a pharmaceutical or FDA regulated environment OR
• High School Degree and 5+ years’ experience in a pharmaceutical or FDA regulated environment.

Preferred Qualifications:

• Familiarity with cGMP maintenance planning, execution and closure thru a Computerized Maintenance Management System (CMMS).
• Familiarity with cGMP calibration planning, execution, and closure thru CMMS
• Experience in building management systems (e.g. Siemens Desigo) is a plus.
• Experience in CMMS (e.g. BMRAM and/or Maximo) is a plus.
• Must be able to prioritize, manage and follow-up on numerous projects and activities
• Must exhibit effective written and verbal communication skills
• Must be detail oriented and exhibit a high degree of flexibility and initiative
• Ability to function efficiently in a diverse, fast paced, changing environment.
• Must be able to work independently as well as part of a team.
• Ability to think critically, and utilize troubleshooting and problem solving skills
• Cell and Gene Therapy experience is a plus