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Senior Quality Assurance Engineer

2 months ago

Atlanta, Georgia, United States Mallinckrodt Pharmaceuticals Full time
Job Summary

Mallinckrodt Pharmaceuticals is seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality of our products and processes.

Key Responsibilities
  • Perform batch record review and document deficiencies
  • Identify exceptions and report exceptions
  • Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
  • Execute line clearances
  • Perform batch record accountability
  • Create and/or revise Quality related SOPs
  • Review and approve exceptions, change controls and CAPAs in the Trackwise module
  • Review of data for release APIs, Excipients, and Finished Bulk Product
  • Perform supplier qualification activities including desk audits and supplier approvals
  • Author and/or review validation documentation including equipment qualification and process validation
  • Participate in, or Lead Root Cause Analysis teams
  • Follow all internal and basic cGMP guidelines for pharmaceutical operations
  • Adhere to all safety rules and maintain 100% completion of all safety required training
  • Maintain Compliance Wire training
Requirements
  • BS in Chemistry, Biology, related science or equivalent combination of education, experience, and competencies
  • Minimum of 5-7 years' experience in Quality Assurance in a pharmaceutical manufacturing environment
  • Excellent communication and leadership skills
  • Knowledge of GMP's for Dosage Products
  • Knowledge of Supplier Quality or Validation Principles
  • Understanding of basic statistical principles, and regulatory expectations
  • Knowledge of Quality Systems
  • Ability to quickly identify, communicate and/or resolve issues
  • Ability to build relationships with partners
  • Good verbal and written communication skills
Competencies
  • Dealing with ambiguity, approachability, decision quality, functional/technical skills, integrity and trust
  • Customer Focus, managing diversity, fairness, managing and measuring work, motivating others
Working Conditions

20% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds

80% office environment which includes sitting for long periods of time and computer use