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Quality Specialist

Company: Ascent
Location: Irvine
Posted on: November 10, 2019

Job Description:

Job Title: Quality SpecialistLocation: Irvine, CA 92618Type: Initial 6 Month Contract with possibility to extend further?Job Responsibilities:To perform compliance activities that ensure required quality and safety standards are being met for our products.Perform compliance activities of complex nature as per schedule and per standards/SOPs.Develop your knowledge to become a SME to the compliance team on topics such as: GMPs, Compliance Activities, Record Retention, Audit, Gap Assessment, Regulatory documentation (Certificates), and Quality Manual.Develop a high level of integrity and have a desire to comply with regulations and standards.Approve, review, and provide meaningful actionable feedback on projects, metrics and documentation.Write and take ownership for compliance SOPs.Participate in external (Health Authority, Notified Body) and internal audits as required.Skills:Knowledge of cGMP regulations for medical device manufacturing operations and validation procedures and practices.Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach.Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.Possess understanding of the relationships between Manufacturing, Quality Assurance, Compliance, R & D and Regulatory Affairs.Education:Minimum: Some college with 2 years directly related experience The ability to fluently read, write, understand and communicate in EnglishPreferred: Bachelor's Degree or equivalent years of related experience

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.

Keywords: Ascent, Irvine , Quality Specialist, Other , Irvine, California

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