QA Specialist, DSM (Project QA) Position Available In Wake, North Carolina

QA Specialist, DSM (Project QA)
Job Locations
US-NC-Holly Springs
Posted Date
6 days ago
(5/5/2025 7:43 PM)
Requisition

ID 2025-34489

Category Quality Assurance Company (Portal Searching) Diosynth Biotechnologies
Position The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Company Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive – what we call Genki. Join us We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States. Job Description What You’ll Do

• Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Participate in streamlining or efficiency improvement initiatives with other Diosynth Biotechnologies sites
• Perform other duties, as assigned Minimum Requirements
• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
• Masters in Life Sciences or Engineering or equivalent with 0 years’ relevant experience
• 1-3 years’ experience in a GMP environment
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility Preferred Requirements
• 2+ years of experience in GMP Quality Assurance and/or similar role
• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software Working & Physical Conditions Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 120 minutes. Ability to sit for prolonged periods of time up to 120 minutes. Ability to conduct activities using repetitive motions that include wrists, hands or fingers. Ability to conduct work that includes moving objects up to 10 pounds.