Sr. Quality System Analyst, Information Technology (contract)

Location:

Austin, TX

Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

Molecular Templates is seeking a highly skilled and highly motivated professional to analyze operational information and technology needs. The Sr. Quality System Analyst will be responsible for the implementation and integration of system and technology initiatives to achieve company goals. The Sr. Quality Analyst will develop, recommend and document plans, standards, procedures and check lists. The Sr. Quality Analyst will also manage technology assets, design and deliver training, provide system and technical support to users and troubleshoot information systems and technology. The position requires an in-depth understanding of implementing technology solutions and improvements. This requires problem solving, system analysis and design knowledge, organizational and time-management skills and verbal and written communication skills; plus, ability to apply attention to detail and manage competing priorities.

Job Responsibilities:

• Conduct system analysis and design, translate business requirements into system designs and applications; prepare functional specifications
• Prepare detailed Requirements and Functional Design documents, and steps required to develop or modify applications
• Develop test plan for programs to assure functionality of the application
• Execute test scripts and document results
• Participate in development and maintenance of thorough, up-to-date, functional and systems documentation, business process flow diagrams and end-user training material
• Prepares reports for workshops, seminars, conferences, meetings and trainings, pertinent to the efficient dispatch of duties
• Involved in error correction and testing of upgrades of the applications as needed
• Prepare and conducts presentations, as needed
• Assist in the development of organizational, system and technology goals; assist in the development of detailed plans for goal accomplishment
• Analyzes information and technology needs from a strategic and operational perspective; makes recommendations
• Participates in management and system/technology meetings
• Remedies technology issues/problems
• Ensures the availability, continuity and security of data and information.
• Utilizes technology to achieve organizational goals
• Develop and manage internal system and technology training, as needed
• Assist in maintenance and testing of the organizational technology plan, including disaster recovery plans and procedures
• Maintain knowledge of trends and innovations in the field of information systems & technology that could benefit the organization; documents findings/rationale and recommendations to supervisors
• Other duties, as assigned

Qualifications:

• Bachelor's degree from accredited institution in Computer Science or related field, required
• Minimum of eight (8) years relevant experience in applications
• Experience with all aspects and elements of a quality system including but not limited to CAPA, SCAR, Supplier Quality, LMS and Document Management
• Experience with QMS platforms like EtQ, Pilgrim, TrackWise, MasterControl, Q-Pulse
• Experience implementing and supporting LIMS
• Experience working in a pharmaceutical manufacturing environment preferred
• Experience with configuration and customization of the QMS application

• Experience working in biotechnology/pharmaceutical industry with compliance standards (21CFR Part 11, SOX),
• Thorough understanding of the Change Control and SDLC process
• Excellent written and verbal communication skills
• Excellent critical thinking and analytical skills
• Excellent organizational, planning and project management skills

• Excellent computer skills with knowledge of enterprise software, development methods, cloud platforms, MS Office

• Ability to synthesize complex information from data from multiple sources
• Ability to apply attention to detail
• Ability to prioritize tasks and manage projects to meet requirements and deadlines
• Ability to work in a fast-paced, time-sensitive, and high-volume environment

Reporting Structure:

This position currently has no supervisory responsibilities. This position reports to the IT Quality Systems Manager Information Technology.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com