lims systems admin.

job summary:
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.

 
 
location: Westborough, Massachusetts
job type: Contract
salary: $50.00 - 75.86 per hour
work hours: 9am to 5pm
education: Bachelors
 
responsibilities:
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.

Quantitative Dimensions: Describe the measurable areas on which this position has direct, or indirect impact. Include areas such as operating budget, sales, cost of goods, number of clients or vendors, and/or number and complexity of clinical studies, etc.

The Principle System Administrator will be accountable for defining the requirements for implementation and management digital systems and managing the requirements for the ongoing operations. This role will work closely with the IT technical lead.

Organizational Context: Describe the organizational positioning of the role; mention the reporting line, level above and below. Include known job family information. If a new position or if an organizational change, attach an organizational chart. Intent is to give a sense of the work environment in which the responsibilities are performed.

The Principle System Administrator will typically report to the Associate Director, Manufacturing Technical Support. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization.

 
qualifications:
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


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.