QA Document Control Coordinator

VIRxSYS is a private biotechnology company in Gaithersburg, Maryland which develops gene therapy treatments for serious diseases utilizing its proprietary lentiviral vector platform (www.virxsys.com).  This is a rapidly growing company currently in Phase II clinical trials for the treatment of HIV/AIDS following exciting results from its Phase I trial.

 

The Company also is building a pipeline of therapies for the treatment of other serious diseases including cancers and genetic diseases.  The Company?s strategy is to in-license technologies and other intellectual property to enhance company?s pipeline of therapies, and ultimately partner or out-license those therapies to biotech and pharmaceutical partners. The Company also will consider taking selected therapies directly to market.

 

VIRxSYS is a collegial, yet dynamic environment that hires only the brightest and most highly motivated scientists, technicians and other professionals.

 

Please visit our website:  www.virxsys.com.



 

QA Document Control Coordinator

 

Scope of Position:

 

The Document Control (DC) Coordinator is an integral and critical position which coordinates system-wide compliance of VIRxSYS to federal regulations promulgated by the FDA under 21 CFR Part 210 and 211 (Good Manufacturing Practice regulations). 

 

Major Responsibilities:Provide Good Manufacturing Practices (GMP) documentation support for Manufacturing, Quality, and other departments within Virxsys.  Coordinate the timely review, revision, approval and issuance of Standard Operating Procedures (SOP?s), Batch Records, Test Procedures, and other records. Maintain and coordinate cGMP support activities such as Employee Training Files, Blood-borne pathogen surveillance program, environmental monitoring, etc. Establish disaster avoidance procedures to maintain security and integrity of Document Control Systems (electronic databases, electronic documents and records).

?  Assist the QA Director in ensuring that only current procedures are utilized company-wide.

?  Issue controlled working documentation for use in manufacturing, testing, labeling of clinical material.

?  Ensure that Virxsys document management systems for control of policies, procedures, and development and production records are compliant with current FDA regulations.

?  Write and revise SOP?s related to Documentation Control system policies and procedures.

?  Effectively follow SOP policies and current GMP?s. 

?  Ensure that documents submitted to QA Document Control are logically structured and follow established document templates.

?  Participate in projects in support of Quality Department goals, such as document audits, inspection support and other projects as required.

 

Educational Requirements:

 

?  Bachelor?s Degree with computer knowledge preferably in design and troubleshooting of computer systems and application software.

?  Knowledge of Software development to serve as a liaison between VIRxSYS and software vendors.

 

 

 Please send CV to employment@virxsys.com