Quality Engineer I

United Therapeutics Corporation•Silver Spring, MD

2d•$64,000 - $85,000•Onsite

About The Position

Ready to put your quality expertise to work where it truly matters? As our next Quality Engineer I, you'll help safeguard the integrity of life-changing therapies—supporting cGMP compliance across our commercial products, clinical supply, and the next generation of APIs, drug substances, drug products, and combination products. If you're someone who thrives on detail, loves continuous improvement, and wants your work to directly support patients waiting for breakthrough medicines—this is your seat at the table. Come build quality into every step of our mission. The Quality Engineer I will provide support to maintain cGMP compliance for UTC commercial products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination products. This role will support the implementation of qualification and validation activities and commercialization including documentation review and process improvement of currently marketed products. Responsibilities for this role also include support of Change Control, Quality Event, and CAPA programs, and supporting management during regulatory agency(ies) inspections, third-party partners, and customer 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