Laboratory Administrator

Job Title: (IS/IT) - Systems Administrator

Location: Westborough, MA

Zip Code: 01581

Duration: 12 Months

Pay Rate: $73.33/hr.

Keyword's: #Westboroughjobs; #SystemsAdministratorjobs.

Start Date: Immediate

We provide a competitive pay and benefits package. This position is offering a pay range of $73.33/hr. however, Belcan considers several factors when extending an offer, including but not limited to education, experience, geographic location, and discipline. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law.

Job Description:

The Principle System Administrator will be responsible for defining the requirements for implementation of software systems and managing the requirements for the ongoing operations as the primary interface between Operations and IT. Some examples of this would be user management, master data configuration and role management. Primary platforms will be LIMS and EBR applications. In addition, they will be responsible for supporting data integrity efforts at the site to ensure compliance to 21CFR Part 11 for manufacturing and lab equipment.

Essential Job Responsibilities: List 10 or fewer primary duties and responsibilities for this position in order of importance and time spent. Include supervisory responsibilities. Focus on responsibilities rather than projects. Avoid being vague or listing many minor duties.

* Develop and maintain system configuration documentation and plan for new product, equipment, and workflows. Provide first line of troubleshooting issues for users.

* Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; Work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.

* Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.

* Develop and provide computerized system training to new users and grant system access and ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Collect and report metrics.

* Manage system updates, change controls and maintenance activities as relating to systems.

* Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.

* Create/manage master data to support existing/new system functionalities.

* Ensures that the integrity and accuracy of all documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.

Qualifications: Identify the levels of knowledge, skills, abilities, experience, education, and certifications required for the position. Knowledge refers to what someone needs to know. Skills and abilities refer to specific talents or capabilities that someone needs to possess or know how to do.

Required

* B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in working with analytical computerized systems

* Prior laboratory hands-on experience with a variety of analytical computerized systems

* Expertise in regulations governing data integrity and computerized systems

* Experience in qualification of analytical equipment, including those with computerized systems

* Experience with electronic document management systems

* Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive

work environment

* Strong knowledge of GMP, SOPs and quality control processes

* Strong knowledge of quality systems and regulatory requirements

* Experience and knowledge in implementation and management of LIMS

* Experience in translating laboratory user requirements to IT implementations

* Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment

* Good to excellent technical writing skills and verbal communication skills

* Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion

* Highly self-motivated and goal oriented

* Will support and demonstrate quality standards to ensure data of highest quality

Preferred

* Experience in a small company and high growth, fast-paced environment

* Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.

* Experience with instrument integration/direct data capture from stand-alone COTS systems to LIMS application