QC-LIMS Administrator

Job Description Summary

The LIMS Administrator will support the Cell and Gene Technical Development and Manufacturing site Laboratory Information System (LIMS). The LIMS Administrator will be responsible for the maintenance, updates and troubleshooting of the LIMS related items. Additionally, the LIMS Administrator will assist with site projects such as system updates and/or enhancements. Customer service and patient focus is a must as deliverables are expected within tight timelines and are expected to be within regulatory guidelines and compliance. Knowledge of GxP Regulations is recommended.
Location: Morris Plains, NJ #LI-Onsite

 

Job Description

Key Responsibilities:

• Support and participate in LIMS related projects for upgrades and enhancements
• Responsible for daily support of end users, and provide end user training
• Assist with investigations and errors in a timely manner
• Maintain master data objects
• Perform ADHOC queries using SQL
• Create and maintain user accounts
• Creation/Revision of product specifications and of standard operating procedures
• Assist with change control impact assessments
• Participate in internal audit reviews of the system and system documentation
• Support site projects and goals where applicable to streamline testing, FDA commitments and source document updates.
• Execute, Create or revise computer system validation documents (i.e., URS, OQ, PQ, etc.)

Essential Requirements:

• Bachelor’s Degree in Biological Sciences or related scientific discipline preferred with minimum of 3 years of  LabWare experience.
• Minimum of 5 years pharmaceutical or biopharmaceutical experience
• Previous experience with validation and/or maintenance of laboratory information systems.
• Working knowledge of GxP LIMS application highly desirable.
• Good documentation and record keeping skills and attention to detail.
• Knowledge of GMP and the Pharmaceutical industry.
• Ability to interact with a variety of organizational levels.
• Demonstrated problem solving skills.
• Ability to work independently with minimal direction and be self-directed to manage competing priorities.

The salary for this position is expected to range between $85,400 and $158,600 per year.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Salary Range

$85,400.00 - $158,600.00

 

Skills Desired

Action-Oriented, Continued Learning, Functional Skills, Gmp Procedures, Managing Ambiguity, Process Optimization, Qa (Quality Assurance), Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence