Open Positions

IT HELPDESK SPECIALIST

Responsibilities:
The IT Helpdesk Specialist will have a second nature in helping end-users and solving technical problems. The successful candidate will work as part of the IT Team and will be able to troubleshoot typical hardware/software PC issues, including the diagnoses of performance issues and the installation/repair of desktops and laptops including all hardware system components, OS installation, setup of software, network settings, and peripherals. The candidate will follow pre-defined validation scripts as defined by the Validation Team for installing validated software onto systems to maintain a validated state, PC imaging and configuration, provide end-user software training; follow, update and create Standard Operating Procedures (SOP), and provide access to secured systems and network locations according to defined procedures. Other responsibilities of the individual include the ability to work with vendors to configure and procure new PCs, equipment, and supplies, while being able to resolve vendor issues and negotiate/research best rates; participate on tasks at all levels including , but not limited to desktop builds, deploys, and inventory control; user account building and maintenance; software rollouts; remote user assistance; virus and malware diagnostics and cleaning; documentation; project planning; and asset tracking; ability to support scientific applications such as LIMS and acquisition software.

Qualifications:
The successful candidates should have 2-3 years of technical support experience. At least 1 year of helpdesk experience in a pharmaceutical R&D or a GXP environment is a plus. Candidates must have exceptional written and verbal communication skills along with a positive attitude. Must possess excellent problem solving skills, time-management skills, and superior organizational skills. Expertise in having to create and maintain technical documentation. Must be able to work in a high pressure, fast-paced, environment and be a strategic thinker with strong analytical troubleshooting skills. Must understand networking principles and Microsoft Active Directory. Must have a demonstrated history working on multiple projects simultaneously. Advanced knowledge and experience of complete MS Office system, 2007 applications (Outlook, Word, Excel, PowerPoint), Windows 2000, XP, and 7. Experience with WAN, LAN, VPN, and WLAN. Must be able to understand scientific applications and participate in regular training to provide support to end users. SharePoint and VMware experience is helpful. Strong consideration is given to candidates with industry standard certifications from, Microsoft, ITIL, or equivalent and/or who have experience with Dell hardware, iPhone, Android.

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 PROJECT MANAGER

Responsibilities:
The Project Manager will work in the bioanalytical chemistry, area. Individuals selected for this position will schedule and supervise method validation, sample analysis for preclinical and/or clinical projects, provide leadership in the delivery of services to clients; review work produced by project teams; ensure staff fulfills their responsibilities in accordance with project contracts and XBL policies, procedures and SOPs. They will also be responsible for taking a lead role in the day-to-day management of major studies; ensure that projects are delivered on time, within budget and according to client expectations.

Qualifications:
Successful candidates must at minimum, possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with a minimum 3-5 years experience as a Project Manager with a CRO or Pharmaceutical company. Prior hands on laboratory experience in bioanalytical sample analysis is highly desirable. This position also requires a minimum of 3 years of experience in project scheduling, and resource/ budget management, team activity coordination and client interaction/management. Experience with the full clinical development process through regulatory submissions is a plus. This position requires candidates to be detailed-oriented, computer proficient in a Windows environment and possesses superior interpersonal and organizational skills.

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QUALITY ASSURANCE AUDITOR

Responsibilities:
The Quality Assurance Auditor will have the responsibilities including but not limited to: inspecting/auditing analytical/bioanalytical studies performed according to Good Laboratory Practices (FDA, EPA, OECD); reviewing study data and reports; auditing software/system validation documents, summarizing findings and reporting to study directors/principal investigators and management; maintaining GLP-required documentation; keeping an accurate schedule of inspection activities; conducting facility, vendor and subcontractor audits.

Qualifications:
The successful candidate will have a BA/BS degree in a related scientific discipline and a minimum 2-yr QA experience working in a GLP-regulated environment; CRO experience is preferred.  Knowledge of government regulations related to clinical/non-clinical research is helpful.  Candidate must be a fast learner who works well with numbers, is detail-oriented and highly organized, works well with people, and has excellent verbal and written communication skills. 

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 VALIDATION SPECIALIST

Responsibilities:
The Validation Specialist will have the immediate tasks of upgrading Analyst Software and to complete Network Acquisition migration for Analyst. Review executed validation packages. Work as part of the validation team throughout the entire Life Cycle of the Computer System Validation (CSV) Project. Perform Validation Risk Assessment and Gap Analysis. Author Validation packages: System Validation Plan, User Requirements Specifications, Requirements Traceability Matrix, Configuration Specifications, Installation Qualification Protocol, Operational Qualification Protocol, Performance Qualification Protocol/User Acceptance Testing, Test Cases/Scripts, and Validation Summary Reports. Handle exceptions and deviation reporting and will develop and revise SOPs. Collaborate across multiple departments for validation protocol development, plans and test scripts. Manage systems to maintain validated state and perform Change Control Procedures. Develop Test Environments for establishing Acceptance Criteria, Configuration Specifications and User Requirements Specifications. Design and implement business workflows. Assess compliance practices and draft recommendations for corrective action. Communicate with Vendors for issues, patches, updates, upgrades and new systems. Configure interfaces for digital importing and exporting of raw data. Perform other duties as assigned.

Qualifications:
The Ideal candidate should have a relevant Bachelor's Degree applicable to a pharmaceutical R&D environment. 4+ years of validation experience in a regulated, GxP environment, with extensive knowledge of GLP and 21 CFR Part 11 regulations. Candidates must have exceptional written and verbal communication skills along with superior organizational skills. Must possess excellent problem solving skills and the ability to quickly and effectively analyze critical issues and develop assessments for risk and impact. Must be able to work in a high pressure, fast-paced environment. Must be able to work independently and manage time with respect to project priorities. Must have thorough understanding of the Bioanalytical Process. Must be able to operate instrumentation for validation development and execution. Advanced knowledge and experience of complete MS Office system. Firm understanding of all associated technology platforms as needed for the projects. Must be able to effectively manage other Laboratory Informatics Systems as assigned. Preferred system experience is a major plus: AB/Sciex Analyst Software, Thermo Watson LIMS, LabLogic Debra LIMS, Waters Empower2 CDS, Thermo Xcalibur / LCquan.

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