Document Control Specialist - Quality Affairs

Artes Medical is a privately held, San Diego-based, medical technology company, focused on developing, manufacturing, and commercializing a new category of permanent aesthetic injectable products for the dermatology and plastic surgery markets. The company's product development activities are centered around its proprietary platform technology and formulations of precision-filtered injectable synthetic microspheres made of polymethylmethacrylate (PMMA) suspended in purified collagen gel.

 

We currently have a need in our Quality Affairs department for a DOCUMENT CONTROL SPECIALIST.  The QA Associate - Document Control Specialist responsible for support to the document change control process through file set up and maintenance, data entry, document distribution.This position will also provide customer service to users of the document change control process. 

 

Responsibilities consist of (but are not limited to) the following activities:Support the Document Change Control processAssign DCO # and create DCO file foldersPerform data entry as requiredDistribute DCO documents for reviewUpdate documents per approved DCOsMaintain organized filing of all approved and original documentation (hard copy and electronic) Maintain Controlled GMP Document binders Distribute and issue controlled binders updatesVerify obsolete document revisions are removedIssue controlled documents to production and product development staff such as batch records and protocols.

 

Requires certification or high level of competency in Microsoft Office applications (Excel, Word, PowerPoint, Access), prior experience in an FDA/ISO regulated environment  and knowledge of cGMP concepts and guidelines .  Successful candidate will have a igh degree of attention to detail, good verbal and written communication skills. Demonstrated ability to work accurately, follow instructions, meet timelines and handle multiple priorities is critical to this position.

 

 

Artes offers an outstanding and dynamic work environment where employees are committed to the success of the company, recognized for their contributions and valued by each other.  We offer a robust compensation and benefits package icluding pre-IPO stock options and bonus programs. 

Please see us on the web at www.artesmedical.com

EOE