Quality Engineer I

United Therapeutics•Silver Spring, MD

22h•Onsite

About The Position

United Therapeutics (UT) is seeking a Quality Engineer I to support cGMP compliance across its commercial products, clinical supply, and the development of novel pharmaceutical therapies and technologies. This role is crucial for ensuring the integrity of life-changing treatments and for supporting the company's mission to develop therapies for rare, deadly diseases and to create manufactured organs to address transplant shortages. The Quality Engineer I will be involved in maintaining cGMP compliance for commercial products, clinical materials, and new product development, including APIs, drug substances, drug products, and combination products. The position will also support qualification and validation activities, documentation review, process improvement, and programs related to Change Control, Quality Events, and CAPA. Additionally, the role involves supporting management during regulatory inspections and audits.

Requirements

Bachelor’s Degree in engineering, chemistry, biology, biochemistry, or related scientific or technical discipline
Ability to define problems, collect data, establish facts, and draw valid conclusions
Strong organizational skills and strong attention to detail
Strong verbal and written communication skills
Strong interpersonal skills and ability to work as an effective team member
Strong computer skills and demonstrated competence to include MS Office applications, database applications, and spreadsheets
Able to work independently with occasional need for guidance

Nice To Haves

1+ years of relevant pharmaceutical industry experience in a cGMP environment
Familiarity with QA and cGMP principles, concepts, industry practices, and standards
Demonstrate knowledge of FDA Quality System regulations and cGMP, 21 CFR Part 11, 210, 211, and 820
A familiarity with EU, and JP GMP regulations
Familiarity with validation practices
Familiarity with pharmaceutical operations (i.e., aseptic filling, etc.), biologics operations, and combination products

Responsibilities

Collaborate and approve GMP related documents (i.e. IOQ and PQ documents, stability protocols, operational protocols and reports, etc.) pertaining to APIs and drug products for accuracy, completeness, and compliance with UT policies, quality system procedures, cGMPs and standards
Provide QA input to process and manufacturing documentation including material specifications, drawings, inspection procedures, manufacturing and packaging procedures, to ensure the resulting products can be adequately manufactured and tested
Assist / collaborate on investigations for quality events, deviations, investigations, out of specifications (OOS), change controls, and corrective and preventive action (CAPA) processes for cGMP events
Provide support to CMO related manufacturing processes, change controls, investigations, and new projects
Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.
Create or assist in the creation of batch records, protocols, summary reports, standard operating procedures, raw material specifications, etc.
Participate in quality system project initiatives and project start-up
Provide support to QA management during regulatory agency inspections (such as FDA) and participate in the closure of internal and regulatory audit observations
Support SME in change management activities and communicate and resolve quality issues with internal departments; escalate complex issues to Quality Management, as needed