Laboratory Information Systems Specialist I

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Laboratory Information Systems Specialist I is responsible for supporting the development, use, and maintenance of GRAM's Laboratory Information Management System (LIMS). Support master data creation and revision, end user support, deliver and participate in the development of training, document authoring and review, and continuous improvement projects.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or a related field.
• Minimum of 5 years related work experience.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Knowledge of general laboratory test methods.
• Knowledge of QA/QC principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.

Preferred Requirements:

• Experience in operation of validated 21 CFR Part 11 compliant computer systems. Prior experience with LabVantage, or similar Laboratory Information Management System (LIMS).
• Knowledge of environmental monitoring programs.
• Experience in computer system change management, specifically related to master data management.

Responsibilities Include (but are not limited to):

• Support Quality Control in the build and/or revision, review, and approval of LIMS master data, including but not limited to products, specifications, and methods, per LIMS procedures.
• LIMS end user subject matter expert (SME).
• Assist the LIMS Manager in supporting end user technical and data entry issues.
• Provide end user on the job training (OJT) for laboratory and production employees where required. Participate in LIMS training development and implementation.
• Assist in revising user procedures and documentation for system enhancements, changes to user requirements, or updates based on business needs.
• Work closely with lab operations to understand existing workflows, challenges, and opportunities for improvement and make recommendations to management.
• Support Laboratory Application Systems Administrator in the Administration of LabVantage LIMS.
• Assist in managing business needs change controls and execute action items for LIMS.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.