GDITs Military Health team is hiring a part-time (20 hours/ week) Product Manufacturing Expert to support the Office of Regulated Activities (ORA) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.
The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products. Learn More HERE
What Youll be Doing:
Provide regulatory support for all manufacturing development and technology transfer activities, interacting with scientific staff and various regulatory agencies.
Provide expert written reviews, briefings, and recommendations for manufacturing developmental medical products.
Participate in meetings and provide input regarding manufacturing compliance.
Review deliverables from outside Sponsors (comment on FDA communications/ packages, any regulatory deliverables, etc.).
Provide expertise on manufacturing-related compliance to GMP.
Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective results.
Work with regulatory and quality teams to ensure that all quality and regulatory standards and requirements are implemented and maintained.
Attend and participate in site visits.
Participate in special projects as required.
What Youll Need:
Bachelor’s Degree in manufacturing, engineering, or related scientific field or the equivalent combination of education, professional training, or work experience.
5+ years of related product manufacturing experience with medical products.
Knowledgeable of CFRs and GMPs.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
Skill & Attributes for Success:
Must be highly organized, detail oriented, and perform independently.
Excellent written and oral communication skills.
What GDIT Can Offer You:
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.