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QA Data Systems Administrator

Arena Pharmaceuticals, Inc.

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Location: San Diego, CA Posted Date: 4/23/2013 Position Type: Full time Job Code: 0344100313 Required Education: Bachelors Degree Areas of Expertise Desired: Quality Assurance

Description

Arena Pharmaceuticals, Inc., a leading San Diego-based biotechnology Company, is seeking a candidate for QA DATA SYSTEMS ADMINISTRATOR.

Arena offers an exciting work environment, competitive salary, excellent benefits package, including 401(k) and stock options.  Email responses to: jobs@arenapharm.com  or apply online at http://www.arenapharm.com/careers.aspx Please reference Job code: 0344100313.

The successful candidate will coordinate and manage the Electronic Data Systems and Electronic Document Management Systems (EDMS) for Quality Assurance.  The position will report to the Director, Quality Assurance and will interact with IT, Regulatory Affairs, Drug Safety and Clinical Operations as well as other departments and manufacturing facilities as necessary.

Essential Duties and Responsibilities:
• Administer regulated data management systems managed or operated by and for Quality Assurance (QA), including but not limited to EDMS, TrackWise, SAP, LIMS, eCTD, Calibration manager, Electronic Laboratory Notebook and OpenText Livelink;
• Train QA users in Arena data management systems, and train Arena staff in QA specific data management systems;
• Configure QA user permissions and workflows as needed within Arena data management systems;
• Project management of QA related computer system projects;
• Manage the QA data management systems;
• Manage the creation, modification, activation and termination of QA system users;
• Process documents for Computer System Validation;
• Support the validation of QA data management systems by executing user acceptance protocols, gathering user requirements and supporting internal and contract validation engineers;
• Provide creative and innovative recommendations and assist in implementation of new document control systems and/or changes to existing document control systems.

Requirements

Education: Minimum of BS in engineering, IT, science, or related discipline

Experience:  
• Minimum of 3 years in the pharmaceutical GMP regulated industry with at least 1-3 years managing progressively more complex computer systems;
• cGMP knowledge and experienced in FDA computer systems guidance and regulations;
• Experience working in regulated data management systems.  Preference for candidates with previous experience in the design, revision or deployment of regulated information systems such as EDMS, CAPA or LIMS;
• Experience providing guidance for deployment of computer systems to internal business units and team members;
• Leadership experience in current and past positions, comfortable defining and driving new governance concepts to deployment, training and maintenance of regulated systems.

Specific Skills:
• Technical competency in GAMP guidelines and knowledgeable in evaluating systems lifecycle principles;
• Sound knowledge of IT Infrastructure and Information Database Systems, preferably in EDMS, TrackWise, SAP, eCTD and OpenText Livelink;
• Ability to succeed in an environment where many processes are still maturing, identify open areas and gaps and form an action plan to remediate;
• Comfortable with rapid change and willing and able to define future processes;
• Excellent oral and written communication skills.

Supervisory Responsibilities:  None – However, Supervisory skills a plus.

Physical Demands/Work Environment:
• Computer keyboarding 70% of time;
• Handling of paper files and notebooks up to 20 lbs;
• Walking between buildings on a daily basis;
• May require travel 15% of time.
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