Quality Operations Specialist III

in Pharma
  • Rockville, MD View on Map
  • Salary: $78,000.00 - $100,000.00
Permanent

Job Detail

  • Experience Level Senior
  • Degree Type Bachelor of Science (BS)
  • Employment Full Time
  • Working Type On Site
  • Job Reference 0000008936
  • Salary Type Annually
  • Industry Pharmaceuticals
  • Selling Points

    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 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

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