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Quality Specialist - I (Assistant)

Quality Specialist - I (Assistant)
Elkton, VA?

The Contractor Quality Specialist (CQS) provides direct Quality support to a virtual production area as part of a Quality IPT (Integrated Production Team) operating model. The CQS, with guidance from the EQA Quality Leadership team, ensures product / process quality and performs activities to assist in the release of product to the marketplace. The CQS performs 100% process document review for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time.
Specific responsibilities include but are not limited to the following:
? Performs 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E). Maintains any tracking databases and logs associated with this review and communicates with the CMO for corrections, as necessary. Completes second person review of release material. Coordinates with Production to discuss, resolve, and eliminate documentation observations.
? Actively participates in the Tier process (DIAL) and uses this forum to escalate concerns and best practices.
? Collaborates with Focused Factory members in the identification and implementation of continuous improvement initiatives and action plans.
? Prioritizes review of process documents / log books in order to maximize cycle-time efficiency.
Quals--
Education:
? Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience.
Required Experience and Skills:
? At least one year of relevant post-degree work experience in manufacturing, or quality position.
? Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
? Attention to detail, flexibility and an awareness of production and attendant quality control problems.
? Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience and Skills:
? Familiarity with vaccine and/or pharmaceutical processing.
? Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
? Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

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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