QA Specialist II, Quality Operations (Combination Products)

QA Specialist II, Quality Operations (Combination Products)

Role overview: The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus.

Responsibilities

• Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to combination products for accuracy, completeness, and compliance with UT policies and procedures.
• Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections, and floor audits, in support of manufacturing and packaging activities.
• Review and disposition manufacturing, packaging, and combination products batch records and components for clinical and commercial processes.
• Review quality control final product data.
• Process rejected lots of raw materials, components and combination products identified for destruction.
• Process retention samples and combination products identified for storage.
• Perform labeling activities, including incoming inspection, issuance, cycle counts, SAP transactions, and reconciliation of labeled and printed components.
• Create and revise standard operating procedures (SOPs) and work instructions.
• Initiate and participate in the closure of quality events and CAPAs assigned to Quality Operations to support cGMP processes, including complete investigations, action items, and effectiveness checks.
• Provide combination products data for annual quality reviews (AQR).
• Communicate and work closely with internal and external partners to resolve quality issues, escalating complex issues to Quality Management.
• Support process initiatives for quality projects, including project plans, timelines, and deliverables.

Qualifications

• Bachelor’s degree in a scientific or related technical discipline.
• 2+ years of relevant pharmaceutical industry experience in a cGMP regulated environment.
• Ability to work independently and as part of a multi-functional team; manage and prioritize workloads, handle stressful situations, meet deadlines, and work extended hours to support business needs.
• Ability to communicate effectively with internal customers at various levels (written and oral).
• Ability to handle confidential company data, projects, information, etc.
• Ability to interpret data in relation to a large number of company procedures and current GMP requirements.
• Experience in review of batch records, production records, and process control records.
• Proficient in Microsoft Excel, Word, and Adobe Acrobat.

Preferred Requirements

• 2+ years of experience in combination products.
• Knowledge of ERP, TrackWise Digital, SAP S4HANA, and MasterControl.

Job Location

On-site at United Therapeutics RTP, North Carolina location 100% of the time.

At United Therapeutics, our mission and vision are one. We aim to innovate for unmet medical needs and benefit our stakeholders. We are bold and unconventional. We have fun and we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs. For additional information on Company benefits, please visit

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.