Sr Quality Systems Admin

Description

ESSENTIAL FUNCTIONS :

• Responsible for site system administration, user support, issue resolution and training related to the use of LV LIMS, Chromeleon CDS, BioVia LES, and other laboratory computer systems
• Write, update, and obsolete procedures related to Chromeleon and laboratory chromatography data, LIMS, and LES
• Creation of new product test procedures based on approved laboratory methods and SOPs
• Installation and interface with new equipment
• Design and implement maintainable configurations, extensions, and customizations
• Develop and execute test scripts, create user manuals and other training material
• Support ad-hoc and custom reporting
• Participate as a team member delivering on approved projects
• Ensure that all activities adhere to relevant policies, SOPs, and regulations
• Work collaboratively across the organization, project team and with other groups as needed to ensure projects and support activities are executed successfully
• Participate in periodic review and disaster recovery programs for computerized systems
• Provide general technical support to IT departments as required
• Part of a team that provides 24 / 7 on-call support
• Adhere to all safety rules and maintain 100% completion of all safety required training

DEPARTMENT SPECIFIC / NON-ESSENTIAL FUNCTIONS :

MINIMUM REQUIREMENTS :

BS or BA in Life Sciences, Engineering, Computer Science, related technical field or equivalent combination of education, experience, and competencies.

A minimum of five years of relevant experience in the pharmaceutical or similarly regulated industry is required. Experience with laboratory computer systems required and preferably as an administrator, especially LabVantage LIMS, Chromeleon CDS, or BioVia LES.

• Self-motivated, demonstrates initiative.
• Ability to write documents in a clear, concise manner.
• Independence and sound decision making capabilities.
• Excellent communication and customer service skills are required to provide clear instructions or information when working with clients, consultants, peers and others in the company.
• Possess sufficient interpersonal skills to be able to function as part of a team.
• Attention to detail and accuracy.
• Experience programming with SQL, PL / SQL

COMPETENCIES :

Approachability, Customer Focus, Drive for Results, Negotiating, Written Communication, Integrity and Trust, Organizing, Priority Setting, Problem Solving, Technical Learning, Time Management

ORGANIZATIONAL RELATIONSHIP / SCOPE :

• Reports to Sr. Quality Manager
• Works under limited supervision.
• Follow established procedures. Work is reviewed for soundness of technical judgment and overall adequacy and accuracy.
• Primarily internal company contacts with frequent inter-departmental contact on routine matters. Contacts include Information Technology, Quality Control, Quality Assurance, R&D, Corporate Quality and Regulatory, Manufacturing, and Logistics.
• Contributes to the completion of milestones associated with specific projects and maintaining existing systems. Failure to achieve results or erroneous decisions or recommendations may cause delays in production or schedules and may impact Quality and Service.

WORKING CONDITIONS :

• 90% Office environment which includes sitting for long periods of time and computer use.
• 10% Laboratory and Plant environment exposure to temperature, noise, chemical or products.
• Occasional Travel is required for projects, training and site support
30+ days ago