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Quality Manager V
















This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing. Requires strong Commissioning and Qualification background.
Key Accountabilities:
Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines
Review and approve validation related studies for assigned areas. These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process
Validation, Equipment and Facility Qualification and Validation Risk Management.
Signatory responsibilities for validation/qualification documents within assigned areas.
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Skills:Technical Competencies:
Working knowledge of cGMPs and regulatory requirements
Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to
validation processes.
Knowledge of vaccines/biologics products and associated technologies
The ability to work on cross functional project teams
Meet/Exceed project timelines/deliverables
Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
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Education:
5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.




Company Description:

About Ascent:


Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.


If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.




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