Senior QA Specialist, Strategic Development

United Therapeutics•Silver Spring, MD

1d•Onsite

About The Position

The Senior QA Specialist, Strategic Development is responsible for Quality Assurance activities for Strategic Development programs, following company policies and procedures and phase-appropriate current Good Manufacturing Practices (cGMP). The role reviews and dispositions executed batch records and associated 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 collaborates with Quality Assurance, Quality Control, Regulatory Affairs, Strategic Clinical Development, and other departments to complete quality-related work. Responsibilities include supporting quality events, CAPAs, and change controls; creating and revising SOPs and work instructions; participating in CMC product development activities; reviewing technical and product-development reports; and assessing temperature excursions related to clinical trial material and clinical retain samples. The position works independently to interpret data and resolve complex quality issues, escalating unresolved concerns to Quality Management, and collaborates with Strategic Development Quality management to meet critical project timelines. This position is 100% onsite at the company’s Silver Spring, Maryland office. The stated salary range is $92,500–$125,000 per year.

Requirements

Bachelor’s degree in science or engineering and at least 5 years of relevant pharmaceutical industry experience in a cGMP environment, or 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 combinations of education and experience may be considered.
Experience reviewing batch records.
Ability to interpret technical data in relation to applicable procedures, specifications, and phase-appropriate current GMP requirements.
Ability to work independently and as part of a team, manage and prioritize workloads, and handle stressful situations and deadlines based on business needs, compliance, and product risk.
Ability to handle confidential company data, projects, and information.
Effective written and oral communication skills for internal and external interactions at various organizational levels.
Proficiency with Microsoft Office and Adobe Acrobat applications.
Knowledge of GxP systems, including Trackwise, MasterControl, and 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 and coordinate 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.
Independently interpret data and solve complex quality issues with internal and external partners, 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.