Senior QA Specialist, Strategic Development

United Therapeutics Corporation•Silver Spring, MD

2d•$92,500 - $125,000•Onsite

About The Position

The Senior QA Specialist, Strategic Development is responsible for Quality Assurance activities supporting Strategic Development programs in accordance with company policies and procedures and phase-appropriate current Good Manufacturing Practices (cGMP). The role reviews and dispositions batch records and manufacturing and packaging documentation for clinical trial material and IND/NDA-supporting batches, and reviews quality control final-product, combination-product release, and stability data. The specialist supports quality events, CAPAs, and change controls; creates and revises SOPs and work instructions; participates in CMC product-development activities; and reviews product-development, method-development, method-validation, and other technical reports. The role also assesses, reviews, and adjudicates temperature-excursion events involving clinical trial material and clinical retain samples. The position works independently on complex quality issues, collaborates with internal and external partners, and coordinates with Strategic Development Quality management to help meet critical project timelines. This role is 100% onsite at the company’s Silver Spring, Maryland office.

Requirements

Bachelor’s degree in science or engineering and at least 5 years of relevant pharmaceutical-industry experience in a cGMP environment; alternatively, a master’s degree in science or engineering and at least 3 years of relevant pharmaceutical-industry experience in a cGMP environment. Commensurate experience and/or a combination of education and experience will be considered.
Ability to work independently and as part of a team, and to manage and prioritize workloads, stressful situations, and deadlines according to business needs, compliance, and product risk.
Experience reviewing batch records.
Ability to interpret technical data in relation to applicable procedures, specifications, and phase-appropriate current GMP requirements.
Ability to handle confidential company data, projects, and information.
Effective written and oral communication skills for communicating internally and externally at various organizational levels.
Proficiency with Microsoft Office and Adobe Acrobat applications.
Knowledge of GxP systems such as Trackwise, MasterControl, or Veeva Vault, and SAP.

Nice To Haves

Master’s degree in science or engineering.
Experience with combination products.
Familiarity with regulatory guidance documents.

Responsibilities

Review and disposition executed batch records and associated manufacturing and packaging documentation for clinical trial material and IND/NDA-supporting batches.
Review quality control final-product, combination-product release, and stability data.
Communicate with Quality Assurance, Quality Control, Regulatory Affairs, Strategic Clinical Development, and other departments to complete quality-related tasks.
Collaborate on and support quality events, CAPAs, and change controls to support cGMP processes.
Create and revise standard operating procedures (SOPs) and work instructions.
Participate in CMC product-development activities and meetings as they relate to Quality work.
Independently interpret data and resolve complex quality issues with minimal guidance, escalating unresolved issues or concerns to Quality Management.
Review product-development reports, method-development reports, method-validation reports, and other technical reports as assigned.
Collaborate with Strategic Development Quality management to ensure critical project timelines are met.
Assess, review, and adjudicate temperature-excursion events related to Clinical Trial Material (CTM) and Clinical Retain Samples (CRS).
Perform other related responsibilities as assigned.