QA Specialist I, Sterile Products

United Therapeutics • Silver Spring, MD

4d • $64,000 - $85,000 • Hybrid

About The Position

The QA Specialist I, Sterile Products is responsible for quality operations activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices and corporate policies and procedures.

Requirements

• Bachelor’s Degree in a scientific or related technical discipline
• Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines based on business needs, compliance, and product risk
• Able to work extended hours to support business needs, as applicable
• Ability to handle confidential company data, projects, information, etc.
• Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization

Nice To Haves

• 1+ years of relevant pharmaceutical industry experience in a cGMP regulated environment
• Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements
• Proficient in Microsoft Excel, Word, and Adobe Acrobat
• Knowledge of Enterprise Resource Planning System (ERP), Trackwise Digital, Systems Application and Products (SAP S4HANA), and electronic documentation management systems

Responsibilities

• Review cGMP documentation (logbooks, pest control, calibration and differential pressure reports, etc.) as it relates to active pharmaceutical ingredients and manufactured drug products for accuracy, completeness, and compliance with UT policies and procedures
• Perform quality assurance functions (aseptic gowning, area line clearance, coding pin verification, and floor audits) in support of manufacturing activities
• Perform batch record reviews of active pharmaceutical Ingredient (API), advanced intermediates, finished product, labeling and packaging, and solution preparations for clinical and commercial processes
• Perform Quality inspections of drug product and bulk package labeling to support manufacturing operations
• Perform review and disposition of components to support manufacturing operations
• Perform issuance and reconciliation of API and finished product bulk labels to support cGMP processes
• Initiate and participate in the closure of quality events and CAPAs assigned to Quality Operations to support cGMP processes, including complete investigations, action items, effectiveness checks, etc.
• Communicate and resolve quality issues with internal departments. Escalate complex issues to Quality Management
• Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.
• For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees