Our client is at the forefront of vaccine development. They have strong financial backing, extended government partnerships and a global impact where you will have the opportunity to work in a collaborative environment.
Job Detail
Job Description
Job Title: Quality Operations Specialist III, Batch Disposition
Job Details:
Our client is seeking a Quality Operations Specialist for Batch Disposition at our Gaithersburg, MD site.
Essential Functions
• Review and approval of executed batch records
• Ensure all records and documentation related to the executed batch record(s)
for completeness, accuracy, and compliance of cGMPs and SOPs.
• Provide Quality support for resolution of deviations related to manufacturing
activities and department. Maintain oversight of deviations within department.
• Implement CAPAs as required
• Author and/or provide review and approval for generation of new or revised
Quality SOPs and other controlled documentation. Author quality documents as
assigned
–
Responsible to ensure appropriate escalation, communication channels are used
to ensure senior management are kept informed of critical issues, as required
–
Responsible to ensure on time execution of activities and team timeline
adherence
Required Knowledge, Skills, and
Abilities
· Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
· Strong communication and organizational skills
· Knowledge in completing investigations and problem resolution
· Knowledge in SAP
· Able to effectively multitask
· The ability to produce high-quality work on complex problems with cross-functional involvement
· Must have strong ability to critically review investigations, results and provide technical conclusions consistent with Quality risk management principles
· Must be action-oriented and customer-focused and skilled in building relationships, problem solving, and planning
· Requires completing routine and complex tasks with little or no supervision
- ShareAustin: